Delivery of Medical Devices for Infection Diagnostics - Part 2
The public procurement includes 44 separated positions. The technical specifications for the individual sub-positions are detailed in Appendix 1.

LOT-0001
ELISA kits for the detection of antibodies against the West Nile virus. Up to 384 tests.
ELISA kits for the detection of antibodies against the West Nile virus. Up to 384 tests. The separated position includes 2 sub-positions, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal: 1. APPLY the catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions, extracts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority as specified in the technical specifications. 2. APPLY a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics. 3. According to the requirements of Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Regulation; there are no recorded data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are paid in at least three EU member states through their respective systems for public funding or their respective health insurance funds.
4. For the separated positions marked as complex (with sub-positions), participants must submit offers for all sub-positions covered by the respective separated position, otherwise they will be removed from the procedure. 5. The participant will be removed from the procedure in case they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid.

LOT-0002
Kit for qualitative and quantitative detection of the gene encoding mtLSU (28S) rRNA of Pneumocystis jiroveci by real-time polymerase chain reaction. Up to 300 tests.
Kit for qualitative and quantitative detection of the gene encoding mtLSU (28S) rRNA of Pneumocystis jiroveci by real-time polymerase chain reaction. Up to 300 tests, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal: 1. APPLY the catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions, extracts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority as specified in the technical specifications. 2. APPLY a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics. 3. According to the requirements of Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Regulation; there are no recorded data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are paid in at least three EU member states through their respective systems for public funding or their respective health insurance funds.
4. For the separated positions marked as complex (with sub-positions), participants must submit offers for all sub-positions covered by the respective separated position, otherwise they will be removed from the procedure. 5. The participant will be removed from the procedure in case they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid.

LOT-0003
Combined kit for quantitative detection and identification of Mycoplasma and Ureaplasma and antibiotic sensitivity to at least 9 antibiotics each in 2 concentrations. Up to 500 tests.
Combined kit for quantitative detection and identification of Mycoplasma and Ureaplasma and antibiotic sensitivity to at least 9 antibiotics each in 2 concentrations. Up to 500 tests, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal: 1. APPLY the catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions, extracts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority as specified in the technical specifications. 2. APPLY a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics. 3. According to the requirements of Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Regulation; there are no recorded data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are paid in at least three EU member states through their respective systems for public funding or their respective health insurance funds.
4. For the separated positions marked as complex (with sub-positions), participants must submit offers for all sub-positions covered by the respective separated position, otherwise they will be removed from the procedure. 5. The participant will be removed from the procedure in case they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid.

LOT-0004
ELISA kit for semi-quantitative detection of IgG antibodies against toxocariasis in serum. Up to 480 tests.
ELISA kit for semi-quantitative detection of IgG antibodies against toxocariasis in serum. Up to 480 tests, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal: 1. APPLY the catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions, extracts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority as specified in the technical specifications. 2. APPLY a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics. 3. According to the requirements of Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Regulation; there are no recorded data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are paid in at least three EU member states through their respective systems for public funding or their respective health insurance funds.
4. For the separated positions marked as complex (with sub-positions), participants must submit offers for all sub-positions covered by the respective separated position, otherwise they will be removed from the procedure. 5. The participant will be removed from the procedure in case they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Regulation No. 7 on the conditions and procedures for compiling the list of medical devices according to Article 30a of the Medical Devices Act and determining the value to which they are paid.

LOT-0005
Semi-quantitative ELISA kit for IgG antibodies against Entamoeba histolytica in human serum. Up to 96 tests.
Semiquantitative ELISA kit for IgG antibodies against Entamoeba histolytica in human serum. Up to 96 tests, detailed in the technical specification - Annex 1.
The participant must submit the following with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents, (manuals, instructions for use from the manufacturer, extracts from the manufacturer's website with catalog numbers and others) that demonstrate that the offered product meets the client's requirements stated in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1, item 1, letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are covered in at least three of the member states of the European Union, through their public funding systems or their respective health insurance funds.
4. The separated items designated as complex /with sub-items/, participants must submit an offer for all sub-items covered by the respective separated item, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0006
Semiquantitative ELISA kit for determining IgG antibodies against cysticercosis (Taenia solium) in human serum. Up to 96 tests.
Semiquantitative ELISA kit for determining IgG antibodies against cysticercosis (Taenia solium) in human serum. Up to 96 tests, detailed in the technical specification - Annex 1.
The participant must submit the following with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents, (manuals, instructions for use from the manufacturer, extracts from the manufacturer's website with catalog numbers and others) that demonstrate that the offered product meets the client's requirements stated in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1, item 1, letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are covered in at least three of the member states of the European Union, through their public funding systems or their respective health insurance funds.
4. The separated items designated as complex /with sub-items/, participants must submit an offer for all sub-items covered by the respective separated item, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0007
ELISA kit for determining IgM antibodies against enteroviruses in human serum. Up to 192 tests.
ELISA kit for determining IgM antibodies against enteroviruses in human serum. Up to 192 tests, detailed in the technical specification - Annex 1.
The participant must submit the following with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents, (manuals, instructions for use from the manufacturer, extracts from the manufacturer's website with catalog numbers and others) that demonstrate that the offered product meets the client's requirements stated in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1, item 1, letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are covered in at least three of the member states of the European Union, through their public funding systems or their respective health insurance funds.
4. The separated items designated as complex /with sub-items/, participants must submit an offer for all sub-items covered by the respective separated item, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0008
Closed system for blood sampling. Up to 7000 pieces.
Closed system for blood sampling. Up to 7000 pieces. The separated item includes 6 sub-items, detailed in the technical specification - Annex 1.
The participant must submit the following with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents, (manuals, instructions for use from the manufacturer, extracts from the manufacturer's website with catalog numbers and others) that demonstrate that the offered product meets the client's requirements stated in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1, item 1, letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL; they are covered in at least three of the member states of the European Union, through their public funding systems or their respective health insurance funds.
4. The separated items designated as complex /with sub-items/, participants must submit an offer for all sub-items covered by the respective separated item, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC / for diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council on medical devices for in vitro diagnostics, and DO NOT MEET the requirements stipulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0009
Rapid immunochromatographic tests for detection of legionella antigen in urine, reacting at room temperature. Up to 80 tests.
Rapid immunochromatographic tests for the detection of Legionella antigen in urine, reacting at room temperature. Up to 80 tests, detailed in the technical specification - Annex 1.
The participant must include with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority laid out in the technical specification.
2. ATTACH a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, Item 1, Letter "b" of the Ordinance;
there have been no recorded data in the IAL and/or EUDAMED for incidents/serious incidents over the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to information provided by IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.
4. For the separated positions marked as complex (with subpositions), participants must submit offers for all subpositions covered by the respective separated position; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not attached the required documents demonstrating the relevant characteristics, a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0010
Quantitative ELISA test for the detection of IFN-gamma production in plasma after stimulation of whole blood with specific antigens of M. tuberculosis. Up to 480 tests.
Quantitative ELISA test for the detection of IFN-gamma production in plasma after stimulation of whole blood with specific antigens of M. tuberculosis. Up to 480 tests, detailed in the technical specification - Annex 1.
The participant must include with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority laid out in the technical specification.
2. ATTACH a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, Item 1, Letter "b" of the Ordinance;
there have been no recorded data in the IAL and/or EUDAMED for incidents/serious incidents over the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to information provided by IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.
4. For the separated positions marked as complex (with subpositions), participants must submit offers for all subpositions covered by the respective separated position; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not attached the required documents demonstrating the relevant characteristics, a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0011
Semi-quantitative ELISA kit for determining IgG antibodies against Leishmania in human serum. Up to 96 tests.
Semi-quantitative ELISA kit for determining IgG antibodies against Leishmania in human serum. Up to 96 tests, detailed in the technical specification - Annex 1.
The participant must include with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority laid out in the technical specification.
2. ATTACH a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, Item 1, Letter "b" of the Ordinance;
there have been no recorded data in the IAL and/or EUDAMED for incidents/serious incidents over the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to information provided by IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.
4. For the separated positions marked as complex (with subpositions), participants must submit offers for all subpositions covered by the respective separated position; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not attached the required documents demonstrating the relevant characteristics, a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0012
Immunochromatographic test for the detection of tularemia reacting at room temperature. Up to 100 tests.
Immunochromatographic test for the detection of tularemia reacting at room temperature. Up to 100 tests, detailed in the technical specification - Annex 1.
The participant must include with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) proving that the offered product meets the requirements of the Contracting Authority laid out in the technical specification.
2. ATTACH a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, Item 1, Letter "b" of the Ordinance;
there have been no recorded data in the IAL and/or EUDAMED for incidents/serious incidents over the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to information provided by IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.
4. For the separated positions marked as complex (with subpositions), participants must submit offers for all subpositions covered by the respective separated position; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not attached the required documents demonstrating the relevant characteristics, a copy of the declaration of conformity with Directive 98/79/EC (for diagnostic reagents constituting in vitro diagnostic medical devices) or a copy of the declaration of conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices according to Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0013
Rapid immunochromatographic tests for the qualitative diagnosis of Trichomonas vaginalis in clinical materials. Up to 100 tests.
Rapid immunochromatographic tests for qualitative diagnosis of Trichomonas vaginalis in clinical materials. Up to 100 tests, detailed in the technical specification - Appendix 1.
To their technical proposal, the participant must:
1. ATTACH manufacturer catalogs with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements of the Contracting Authority set out in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Ordinance; there are no registered data in the Bulgarian Drug Agency (ИАЛ) and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices over the last 18 months according to information provided by ИАЛ; they are reimbursed in at least three of the EU member states, through their respective public funding systems or their respective health insurance funds.
4. For the designated positions, marked as complex (with subpositions), participants must submit an offer for all subpositions covered by the respective designated position, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DOES NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0014
Diagnostic ELISA kit for the detection of IgM and IgG against R. conorii with included IgG/RF adsorbent. Up to 192 tests.
Diagnostic ELISA kit for the detection of IgM and IgG against R. conorii with included IgG/RF adsorbent. Up to 192 tests, detailed in the technical specification - Appendix 1.
To their technical proposal, the participant must:
1. ATTACH manufacturer catalogs with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements of the Contracting Authority set out in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Ordinance; there are no registered data in the Bulgarian Drug Agency (ИАЛ) and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices over the last 18 months according to information provided by ИАЛ; they are reimbursed in at least three of the EU member states, through their respective public funding systems or their respective health insurance funds.
4. For the designated positions, marked as complex (with subpositions), participants must submit an offer for all subpositions covered by the respective designated position, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DOES NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0015
Rapid immunochromatographic tests for qualitative diagnosis of Cryptosporidium /Giardia/Entamoeba in fecal samples. Up to 100 tests.
Rapid immunochromatographic tests for qualitative diagnosis of Cryptosporidium /Giardia/Entamoeba in fecal samples. Up to 100 tests, detailed in the technical specification - Appendix 1.
To their technical proposal, the participant must:
1. ATTACH manufacturer catalogs with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements of the Contracting Authority set out in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Ordinance; there are no registered data in the Bulgarian Drug Agency (ИАЛ) and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices over the last 18 months according to information provided by ИАЛ; they are reimbursed in at least three of the EU member states, through their respective public funding systems or their respective health insurance funds.
4. For the designated positions, marked as complex (with subpositions), participants must submit an offer for all subpositions covered by the respective designated position, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DOES NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0016
Microagglutination test for the detection of total anti-Brucella antibodies, with diluent. Up to 576 tests.
Microagglutination test for the detection of total anti-Brucella antibodies, with diluent. Up to 576 tests, detailed in the technical specification - Appendix 1.
To their technical proposal, the participant must:
1. ATTACH manufacturer catalogs with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements of the Contracting Authority set out in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices comply with the requirements of the Medical Devices Act; the offered medical devices are included in the list under Article 1, item 1, letter “b” of the Ordinance; there are no registered data in the Bulgarian Drug Agency (ИАЛ) and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices over the last 18 months according to information provided by ИАЛ; they are reimbursed in at least three of the EU member states, through their respective public funding systems or their respective health insurance funds.
4. For the designated positions, marked as complex (with subpositions), participants must submit an offer for all subpositions covered by the respective designated position, otherwise they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DOES NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedures for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are reimbursed.

LOT-0017
ELISA kit for determining cytomegalovirus (CMV) aIgG avidity, including urea. Up to 288 tests.
ELISA kit for determining cytomegalovirus (CMV) aIgG avidity, including urea. Up to 288 tests, detailed in the technical specification - Appendix 1.
The participant must attach the following to their technical proposal:
1. Attach catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, and others) demonstrating that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. Attach a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, item 1, letter "b" of the Ordinance;
there have been no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, nor for batches blocked or withdrawn from the market for safety-related reasons in the last 18 months according to information provided by the IAL;
the same are reimbursed in at least three EU member states through their respective public funding payment systems or health insurance funds.
4. For lots marked as complex (with sub-lots), participants must submit offers for all sub-lots covered by the corresponding lot; otherwise, they will be eliminated from the procedure.
5. The participant is excluded from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis, and does not comply with the requirements specified in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0018
ELISA kits for measles. Up to 1152 tests.
ELISA kits for measles. Up to 1152 tests. The lot includes 4 sub-lots, detailed in the technical specification - Appendix 1.
The participant must attach the following to their technical proposal:
1. Attach catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, and others) demonstrating that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. Attach a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, item 1, letter "b" of the Ordinance;
there have been no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, nor for batches blocked or withdrawn from the market for safety-related reasons in the last 18 months according to information provided by the IAL;
the same are reimbursed in at least three EU member states through their respective public funding payment systems or health insurance funds.
4. For lots marked as complex (with sub-lots), participants must submit offers for all sub-lots covered by the corresponding lot; otherwise, they will be eliminated from the procedure.
5. The participant is excluded from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis, and does not comply with the requirements specified in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0019
ELISA kits for rubella. Up to 960 tests.
ELISA kits for rubella. Up to 960 tests. The lot includes 4 sub-lots, detailed in the technical specification - Appendix 1.
The participant must attach the following to their technical proposal:
1. Attach catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, and others) demonstrating that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. Attach a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, item 1, letter "b" of the Ordinance;
there have been no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, nor for batches blocked or withdrawn from the market for safety-related reasons in the last 18 months according to information provided by the IAL;
the same are reimbursed in at least three EU member states through their respective public funding payment systems or health insurance funds.
4. For lots marked as complex (with sub-lots), participants must submit offers for all sub-lots covered by the corresponding lot; otherwise, they will be eliminated from the procedure.
5. The participant is excluded from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis, and does not comply with the requirements specified in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0020
ELISA kits for determining antibodies against Brucella in human serum. up to 384 tests.
ELISA kits for determining antibodies against Brucella in human serum. Up to 384 tests. The lot includes 2 sub-lots, detailed in the technical specification - Appendix 1.
The participant must attach the following to their technical proposal:
1. Attach catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, and others) demonstrating that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. Attach a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, item 1, letter "b" of the Ordinance;
there have been no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, nor for batches blocked or withdrawn from the market for safety-related reasons in the last 18 months according to information provided by the IAL;
the same are reimbursed in at least three EU member states through their respective public funding payment systems or health insurance funds.
4. For lots marked as complex (with sub-lots), participants must submit offers for all sub-lots covered by the corresponding lot; otherwise, they will be eliminated from the procedure.
5. The participant is excluded from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis, and does not comply with the requirements specified in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid.

LOT-0021
ELISA kits for determining antibodies against Yersinia in human serum. Up to 1344 tests.
ELISA kits for determining antibodies against Yersinia in human serum. Up to 1344 tests. The lot includes 3 sub-lots, detailed in the technical specification - Appendix 1.
The participant must attach the following to their technical proposal:
1. Attach catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, and others) demonstrating that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. Attach a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis.
3. According to the requirements of Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1, item 1, letter "b" of the Ordinance;
there have been no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, nor for batches blocked or withdrawn from the market for safety-related reasons in the last 18 months according to information provided by the IAL;
the same are reimbursed in at least three EU member states through their respective public funding payment systems or health insurance funds.
4. For lots marked as complex (with sub-lots), participants must submit offers for all sub-lots covered by the corresponding lot; otherwise, they will be eliminated from the procedure.
5. The participant is excluded from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council for medical devices for in vitro diagnosis, and does not comply with the requirements specified in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Medical Devices Act and for determining the value to which they are paid. Set for qualitative detection and differentiation of Giardia duodenalis (syn. G. lamblia or G. intestinalis), Cryptosporidium spp. and Entamoeba histolytica using multiplex polymerase chain reaction in real-time. Up to 96 tests.
Set for qualitative detection and differentiation of Giardia duodenalis (syn. G. lamblia or G. intestinalis), Cryptosporidium spp. and Entamoeba histolytica using multiplex polymerase chain reaction in real-time. Up to 96 tests, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal:
1. APPLY catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) showing that the offered product meets the requirements of the Contracting Authority specified in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 item 1 letter “b“ of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For the packages marked as complex (with sub-items), participants must submit an offer for all sub-items covered by the respective package; otherwise, they will be removed from the procedure.
5. The participant is removed from the procedure if they have not attached the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostics, and do not meet the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices according to Art. 30a of the Medical Devices Act and for determining the value to which they are reimbursed.

LOT-0023
Set for qualitative detection of Toxoplasma gondii using polymerase chain reaction in real-time. Up to 288 tests.
Set for qualitative detection of Toxoplasma gondii using polymerase chain reaction in real-time. Up to 288 tests, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal:
1. APPLY catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) showing that the offered product meets the requirements of the Contracting Authority specified in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 item 1 letter “b“ of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For the packages marked as complex (with sub-items), participants must submit an offer for all sub-items covered by the respective package; otherwise, they will be removed from the procedure.
5. The participant is removed from the procedure if they have not attached the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostics, and do not meet the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices according to Art. 30a of the Medical Devices Act and for determining the value to which they are reimbursed.

LOT-0024
Set for qualitative detection of Leishmania spp. using polymerase chain reaction in real-time. Up to 96 tests.
Set for qualitative detection of Leishmania spp. using polymerase chain reaction in real-time. Up to 96 tests, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal:
1. APPLY catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) showing that the offered product meets the requirements of the Contracting Authority specified in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 item 1 letter “b“ of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For the packages marked as complex (with sub-items), participants must submit an offer for all sub-items covered by the respective package; otherwise, they will be removed from the procedure.
5. The participant is removed from the procedure if they have not attached the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostics, and do not meet the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices according to Art. 30a of the Medical Devices Act and for determining the value to which they are reimbursed.

LOT-0025
Set for detection and differentiation of Borrelia, Anaplasma & Coxiella using Real-Time PCR. Up to 384 reactions.
Set for detection and differentiation of Borrelia, Anaplasma & Coxiella using Real-Time PCR. Up to 384 reactions, detailed in the technical specification - Appendix 1.
The participant must attach to their technical proposal:
1. APPLY catalogs of the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, etc.) showing that the offered product meets the requirements of the Contracting Authority specified in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 item 1 letter “b“ of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by the IAL;
they are reimbursed in at least three EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For the packages marked as complex (with sub-items), participants must submit an offer for all sub-items covered by the respective package; otherwise, they will be removed from the procedure.
5. The participant is removed from the procedure if they have not attached the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents, which are in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostics, and do not meet the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 for the conditions and procedures for compiling a list of medical devices according to Art. 30a of the Medical Devices Act and for determining the value to which they are reimbursed.

LOT-0026
EliSpot set for proving IFN-gamma production from isolated mononuclear cells after stimulation, containing peptide antigens from ESAT-6 and CFP-10 of M. tuberculosis in two separate mixes. Up to 120 tests.
EliSpot kit for detecting IFN-gamma production from isolated mononuclear cells after stimulation, containing peptide antigens from ESAT-6 and CFP-10 of M. tuberculosis in two separate mixtures. Up to 120 tests, detailed in the technical specification - Annex 1.
The participant must attach with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that clearly show that the offered product meets the requirements of the Contracting Authority set forth in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council regarding medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Device Act;
the offered medical devices are included in the list under Art. 1, item 1, letter "b" of the Regulation;
there are no registered data in the National Medical Device Agency or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or recalled from the market for reasons related to the safety of medical devices in the last 18 months as per information provided by the National Medical Device Agency;
they are reimbursed in at least three of the EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For designated complex lots (with sublots), participants must submit offers for all sublots encompassed by the respective designated lot; otherwise, they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not attached the required documents proving the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)), or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council regarding medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed.

LOT-0027
ELISA kits for detecting Parvovirus B19. Up to 960 tests.
ELISA kits for detecting Parvovirus B19. Up to 960 tests. The designated lot includes 2 sublots, detailed in the technical specification - Annex 1.
The participant must attach with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that clearly show that the offered product meets the requirements of the Contracting Authority set forth in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council regarding medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Device Act;
the offered medical devices are included in the list under Art. 1, item 1, letter "b" of the Regulation;
there are no registered data in the National Medical Device Agency or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or recalled from the market for reasons related to the safety of medical devices in the last 18 months as per information provided by the National Medical Device Agency;
they are reimbursed in at least three of the EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For designated complex lots (with sublots), participants must submit offers for all sublots encompassed by the respective designated lot; otherwise, they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not attached the required documents proving the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)), or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council regarding medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed.

LOT-0028
ELISA kit for determining IgM antibodies against coxsackie viruses in human serum. Up to 96 tests.
ELISA kit for determining IgM antibodies against coxsackie viruses in human serum. Up to 96 tests, detailed in the technical specification - Annex 1.
The participant must attach with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that clearly show that the offered product meets the requirements of the Contracting Authority set forth in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council regarding medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Device Act;
the offered medical devices are included in the list under Art. 1, item 1, letter "b" of the Regulation;
there are no registered data in the National Medical Device Agency or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or recalled from the market for reasons related to the safety of medical devices in the last 18 months as per information provided by the National Medical Device Agency;
they are reimbursed in at least three of the EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For designated complex lots (with sublots), participants must submit offers for all sublots encompassed by the respective designated lot; otherwise, they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not attached the required documents proving the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)), or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council regarding medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed.

LOT-0029
Rapid antigen test for detecting SARS-CoV-2 in human nasopharyngeal secretions. Up to 100 tests.
Rapid antigen test for detecting SARS-CoV-2 in human nasopharyngeal secretions. Up to 100 tests, detailed in the technical specification - Annex 1.
The participant must attach with their technical proposal:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that clearly show that the offered product meets the requirements of the Contracting Authority set forth in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council regarding medical devices for in vitro diagnostics.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Device Act;
the offered medical devices are included in the list under Art. 1, item 1, letter "b" of the Regulation;
there are no registered data in the National Medical Device Agency or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or recalled from the market for reasons related to the safety of medical devices in the last 18 months as per information provided by the National Medical Device Agency;
they are reimbursed in at least three of the EU member states through their respective public funding payment systems or their respective health insurance funds.

4. For designated complex lots (with sublots), participants must submit offers for all sublots encompassed by the respective designated lot; otherwise, they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not attached the required documents proving the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices (or equivalent)), or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and the Council regarding medical devices for in vitro diagnostics, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedures for preparing a list of medical devices under Article 30a of the Medical Device Act and for determining the value up to which they are reimbursed.

LOT-0030
Test for detecting allergen-specific IgE antibodies simultaneously against the following allergens: bee venom; wasp venom; European hornet venom; phospholipase A2 from bee venom (rApi m1), hyaluronidase from bee venom (rApi m2), ikarapine from bee venom (rApi m10), antigen 5 from the venom of the common wasp (rVes v5), phospholipase A1 from the venom of the common wasp (rVes v1). Up to 64 tests.
Test for proving allergen-specific IgE antibodies, simultaneously, against the following allergens: bee venom; wasp venom; venom from European hornet; phospholipase A2 from bee venom (rApi m1), hyaluronidase from bee venom (rApi m2), icarapin from bee venom (rApi m10), antigen 5 from common wasp venom (rVes v5), phospholipase A1 from common wasp venom (rVes v1). Up to 64 tests, detailed in the technical specification - Appendix 1.

In their technical proposal, the participant must:
1. ATTACH catalogs of the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer’s instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that show that the offered product meets the requirements of the Contracting Authority set in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnosis.
3. In accordance with the requirements of Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1 item 1 letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the past 18 months, as well as for blocked or recalled batches from the market due to reasons related to the safety of medical devices in the past 18 months according to information provided by the IAL; they are reimbursed in at least three of the Member States of the European Union, through their respective public funding payment systems or their respective health insurance funds.

4. The separated positions marked as complex (with sub-positions), the participants must submit an offer for all sub-positions covered by the respective separated position; otherwise, they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT COMPLY WITH the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed.

LOT-0031
Real-time PCR kit for the detection and quantitative determination of DNA of Listeria monocytogenes. Up to 220 tests.
Real-time PCR kit for the detection and quantitative determination of DNA of Listeria monocytogenes. Up to 220 tests, detailed in the technical specification - Appendix 1.

In their technical proposal, the participant must:
1. ATTACH catalogs of the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer’s instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that show that the offered product meets the requirements of the Contracting Authority set in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnosis.
3. In accordance with the requirements of Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1 item 1 letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the past 18 months, as well as for blocked or recalled batches from the market due to reasons related to the safety of medical devices in the past 18 months according to information provided by the IAL; they are reimbursed in at least three of the Member States of the European Union, through their respective public funding payment systems or their respective health insurance funds.

4. The separated positions marked as complex (with sub-positions), the participants must submit an offer for all sub-positions covered by the respective separated position; otherwise, they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT COMPLY WITH the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed.

LOT-0032
Multiplex real-time PCR kit for detecting DNA of Mycoplasma pneumoniae and Chlamydophila pneumoniae. Up to 400 tests.
Multiplex real-time PCR kit for detecting DNA of Mycoplasma pneumoniae and Chlamydophila pneumoniae. Up to 400 tests, detailed in the technical specification - Appendix 1.

In their technical proposal, the participant must:
1. ATTACH catalogs of the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer’s instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that show that the offered product meets the requirements of the Contracting Authority set in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnosis.
3. In accordance with the requirements of Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1 item 1 letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the past 18 months, as well as for blocked or recalled batches from the market due to reasons related to the safety of medical devices in the past 18 months according to information provided by the IAL; they are reimbursed in at least three of the Member States of the European Union, through their respective public funding payment systems or their respective health insurance funds.

4. The separated positions marked as complex (with sub-positions), the participants must submit an offer for all sub-positions covered by the respective separated position; otherwise, they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT COMPLY WITH the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed.

LOT-0033
Real-time PCR kit for the qualitative detection of Legionella pneumophila. Up to 280 tests.
Real-time PCR kit for the qualitative detection of Legionella pneumophila. Up to 280 tests, detailed in the technical specification - Appendix 1.

In their technical proposal, the participant must:
1. ATTACH catalogs of the manufacturing companies with catalog numbers and/or other documents (guides, manufacturer’s instructions for use, extracts from the manufacturer's website with catalog numbers, etc.) that show that the offered product meets the requirements of the Contracting Authority set in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnosis.
3. In accordance with the requirements of Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed, the participant must declare that: the offered medical devices meet the requirements of the Medical Devices Act; the offered medical devices are included in the list under Art. 1 item 1 letter “b” of the Regulation; there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the past 18 months, as well as for blocked or recalled batches from the market due to reasons related to the safety of medical devices in the past 18 months according to information provided by the IAL; they are reimbursed in at least three of the Member States of the European Union, through their respective public funding payment systems or their respective health insurance funds.

4. The separated positions marked as complex (with sub-positions), the participants must submit an offer for all sub-positions covered by the respective separated position; otherwise, they will be removed from the procedure.
5. The participant will be removed from the procedure if they have not submitted the required documents to prove the respective characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents that represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for medical devices for in vitro diagnostics, and DO NOT COMPLY WITH the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 regarding the conditions and procedure for drafting a list of medical devices according to Art. 30a of the Medical Devices Act and determining the value up to which they are reimbursed.

LOT-0034
Test for proving the antigen of Cryptococcus neoformans, based on agglutination with latex particles loaded with monoclonal antibodies for detection of glucuronoxylomannan-GXM in serum, BAL, cerebrospinal fluid, and urine. Up to 120 tests. Test for the detection of the antigen of Cryptococcus neoformans, based on latex particle agglutination, loaded with monoclonal antibody for the detection of glucuronoxylomannan-GXM in serum, BAL, cerebrospinal fluid, and urine. Up to 120 tests, detailed in the technical specification - Appendix 1.

The participant must include the following with their technical proposal:
1. ATTACH catalogs of the manufacturers with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Law on Medical Devices;
the offered medical devices are included in the list under Article 1, point 1, letter “b” of the Regulation;
there are no registered data in the Bulgarian Drug Agency and/or EUDAMED for incidents/serious incidents in the last 18 months, and there are no blocked or recalled batches for reasons related to the safety of medical devices in the last 18 months as provided by information from the Bulgarian Drug Agency;
they are reimbursed in at least three EU member states through their corresponding public funding systems or their respective health insurance funds.
4. For the lots marked as complex (with sub-items), participants must submit offers for all sub-items covered by the relevant lot; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not submitted the required documents to prove the respective characteristics, copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed.

LOT-0035
ELISA tests for Legionella. Up to 672 tests.
ELISA tests for Legionella. Up to 672 tests. The lot includes 2 sub-items, detailed in the technical specification - Appendix 1.
The participant must include the following with their technical proposal:
1. ATTACH catalogs of the manufacturers with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Law on Medical Devices;
the offered medical devices are included in the list under Article 1, point 1, letter “b” of the Regulation;
there are no registered data in the Bulgarian Drug Agency and/or EUDAMED for incidents/serious incidents in the last 18 months, and there are no blocked or recalled batches for reasons related to the safety of medical devices in the last 18 months as provided by information from the Bulgarian Drug Agency;
they are reimbursed in at least three EU member states through their corresponding public funding systems or their respective health insurance funds.
4. For the lots marked as complex (with sub-items), participants must submit offers for all sub-items covered by the relevant lot; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not submitted the required documents to prove the respective characteristics, copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed.

LOT-0036
ELISA test for the detection of Lyme disease in human serum. Up to 6720 tests.
ELISA test for the detection of Lyme disease in human serum. Up to 6720 tests. The lot includes 2 sub-items, detailed in the technical specification - Appendix 1.
The participant must include the following with their technical proposal:
1. ATTACH catalogs of the manufacturers with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Law on Medical Devices;
the offered medical devices are included in the list under Article 1, point 1, letter “b” of the Regulation;
there are no registered data in the Bulgarian Drug Agency and/or EUDAMED for incidents/serious incidents in the last 18 months, and there are no blocked or recalled batches for reasons related to the safety of medical devices in the last 18 months as provided by information from the Bulgarian Drug Agency;
they are reimbursed in at least three EU member states through their corresponding public funding systems or their respective health insurance funds.
4. For the lots marked as complex (with sub-items), participants must submit offers for all sub-items covered by the relevant lot; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not submitted the required documents to prove the respective characteristics, copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed.

LOT-0037
Immunoblot tests for the detection of Lyme disease in human serum and ELISA tests for the detection of Lyme disease in human serum and cerebrospinal fluid. Up to 3260 tests.
Immunoblot tests for the detection of Lyme disease in human serum and ELISA tests for the detection of Lyme disease in human serum and cerebrospinal fluid. Up to 3260 tests. The lot includes 4 sub-items, detailed in the technical specification - Appendix 1.
The participant must include the following with their technical proposal:
1. ATTACH catalogs of the manufacturers with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Article 37, Paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed, the participant must declare that:
the offered medical devices meet the requirements of the Law on Medical Devices;
the offered medical devices are included in the list under Article 1, point 1, letter “b” of the Regulation;
there are no registered data in the Bulgarian Drug Agency and/or EUDAMED for incidents/serious incidents in the last 18 months, and there are no blocked or recalled batches for reasons related to the safety of medical devices in the last 18 months as provided by information from the Bulgarian Drug Agency;
they are reimbursed in at least three EU member states through their corresponding public funding systems or their respective health insurance funds.
4. For the lots marked as complex (with sub-items), participants must submit offers for all sub-items covered by the relevant lot; otherwise, they will be disqualified from the procedure.
5. The participant will be disqualified from the procedure if they have not submitted the required documents to prove the respective characteristics, copy of the Declaration of Conformity with Directive 98/79/EC (for in vitro diagnostic medical devices) (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices and DO NOT MEET the requirements stipulated in Article 37, paragraph 1 of Ordinance No. 7 on the conditions and procedure for compiling a list of medical devices under Article 30a of the Law on Medical Devices and for determining the value up to which they are reimbursed.

LOT-0038
Set for the detection of Bordetella pertussis, B. parapertussis, B. bronchiseptica, and B. holmesii by real-time PCR. Up to 250 tests.
Set for the detection of Bordetella pertussis, B. parapertussis, B. bronchiseptica and B. holmesii by real-time PCR. Up to 250 tests, detailed in the technical specification - Appendix 1.
Participants must:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, which represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 (1)(b) of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for withdrawn or recalled batches for reasons related to the safety of medical devices in the last 18 months according to information provided by the IAL;
they are compensated in at least three of the EU member states through their respective public funding systems or their respective health insurance funds.
4. For the specific lots marked as complex /with sub-lots/, participants must submit an offer for all sub-lots covered by the respective separated lot, otherwise they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated.

LOT-0039
Rapid immunochromatographic tests for visceral leishmaniasis: to be performed with peripheral or venous blood or serum. Up to 48 tests.
Rapid immunochromatographic tests for visceral leishmaniasis: to be performed with peripheral or venous blood or serum. Up to 48 tests, detailed in the technical specification - Appendix 1.
Participants must:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, which represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 (1)(b) of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for withdrawn or recalled batches for reasons related to the safety of medical devices in the last 18 months according to information provided by the IAL;
they are compensated in at least three of the EU member states through their respective public funding systems or their respective health insurance funds.
4. For the specific lots marked as complex /with sub-lots/, participants must submit an offer for all sub-lots covered by the respective separated lot, otherwise they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated.

LOT-0040
ELISA kits for semi-quantitative indirect detection of IgM antibodies in human serum and plasma against influenza viruses. Up to 384 tests.
ELISA kits for semi-quantitative indirect detection of IgM antibodies in human serum and plasma against influenza viruses. Up to 384 tests. The separated lot includes 2 sub-lots, detailed in the technical specification - Appendix 1.
Participants must:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, which represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 (1)(b) of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for withdrawn or recalled batches for reasons related to the safety of medical devices in the last 18 months according to information provided by the IAL;
they are compensated in at least three of the EU member states through their respective public funding systems or their respective health insurance funds.
4. For the specific lots marked as complex /with sub-lots/, participants must submit an offer for all sub-lots covered by the respective separated lot, otherwise they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated.

LOT-0041
ELISA kit for semi-quantitative indirect detection of IgM antibodies against parainfluenza viruses in human serum and plasma. Up to 96 tests.
ELISA kit for semi-quantitative indirect detection of IgM antibodies against parainfluenza viruses in human serum and plasma. Up to 96 tests, detailed in the technical specification - Appendix 1.
Participants must:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers and others) from which it is evident that the offered product meets the requirements set by the Contracting Authority in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, which represent in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices.
3. According to the requirements of Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated, the participant must declare that:
the offered medical devices meet the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Art. 1 (1)(b) of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for withdrawn or recalled batches for reasons related to the safety of medical devices in the last 18 months according to information provided by the IAL;
they are compensated in at least three of the EU member states through their respective public funding systems or their respective health insurance funds.
4. For the specific lots marked as complex /with sub-lots/, participants must submit an offer for all sub-lots covered by the respective separated lot, otherwise they will be removed from the procedure.
5. A participant will be removed from the procedure if they have not submitted the required documents to prove the relevant characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC /for the diagnostic reagents, representing in vitro diagnostic medical devices (or equivalent) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in vitro diagnostic medical devices, and DO NOT MEET the requirements regulated in Art. 37, para. 1 of REGULATION No. 7 on the conditions and procedure for compiling a list of medical devices under Art. 30a of the Medical Devices Act and determining the value up to which they are compensated.

LOT-0042
Diagnostic ELISA kit for the detection of class A antibodies against Salmonella typhi. Up to 96 tests.
Diagnostic ELISA kit for the detection of class A antibodies against Salmonella typhi. Up to 96 tests, detailed in the technical specification - Appendix 1.
The participant must:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, and others) showing that the offered product meets the requirements of the Contracting Authority set out in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in-vitro diagnostic medical devices.
3. According to the requirements of Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedures for the compilation of the list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1 item 1 letter “b” of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by IAL;
they are reimbursed in at least three EU member states through their respective public funding systems or their respective health insurance funds.

4. For the designated complex lots (with sub-lots), the participants must submit an offer for all sub-lots covered by the relevant lot; otherwise, they will be disqualified from the procedure.
5. A participant is disqualified from the procedure if they fail to provide the required documents evidencing the corresponding characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in-vitro diagnostics, and DO NOT COMPLY WITH the requirements stipulated in Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedures for compiling the list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are paid.

LOT-0043
Diagnostic ELISA kit for the detection of class G antibodies against Salmonella typhi. Up to 96 tests.
Diagnostic ELISA kit for the detection of class G antibodies against Salmonella typhi. Up to 96 tests, detailed in the technical specification - Appendix 1.
The participant must:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, and others) showing that the offered product meets the requirements of the Contracting Authority set out in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in-vitro diagnostic medical devices.
3. According to the requirements of Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedures for the compilation of the list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1 item 1 letter “b” of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by IAL;
they are reimbursed in at least three EU member states through their respective public funding systems or their respective health insurance funds.

4. For the designated complex lots (with sub-lots), the participants must submit an offer for all sub-lots covered by the relevant lot; otherwise, they will be disqualified from the procedure.
5. A participant is disqualified from the procedure if they fail to provide the required documents evidencing the corresponding characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in-vitro diagnostics, and DO NOT COMPLY WITH the requirements stipulated in Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedures for compiling the list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are paid.

LOT-0044
Diagnostic ELISA kit for the detection of class M antibodies against Salmonella typhi. Up to 96 tests.
Diagnostic ELISA kit for the detection of class M antibodies against Salmonella typhi. Up to 96 tests, detailed in the technical specification - Appendix 1.
The participant must:
1. ATTACH catalogs from the manufacturing companies with catalog numbers and/or other documents (manuals, manufacturer's instructions for use, excerpts from the manufacturer's website with catalog numbers, and others) showing that the offered product meets the requirements of the Contracting Authority set out in the technical specification.
2. ATTACH a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in-vitro diagnostic medical devices.
3. According to the requirements of Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedures for the compilation of the list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are paid, the participant must declare that:
the offered medical devices comply with the requirements of the Medical Devices Act;
the offered medical devices are included in the list under Article 1 item 1 letter “b” of the Regulation;
there are no registered data in the IAL and/or EUDAMED for incidents/serious incidents in the last 18 months, as well as for batches blocked or withdrawn from the market for reasons related to the safety of medical devices in the last 18 months according to the information provided by IAL;
they are reimbursed in at least three EU member states through their respective public funding systems or their respective health insurance funds.

4. For the designated complex lots (with sub-lots), the participants must submit an offer for all sub-lots covered by the relevant lot; otherwise, they will be disqualified from the procedure.
5. A participant is disqualified from the procedure if they fail to provide the required documents evidencing the corresponding characteristics, a copy of the Declaration of Conformity with Directive 98/79/EC (for diagnostic reagents representing in vitro diagnostic medical devices) or a copy of the Declaration of Conformity with Regulation (EU) 2017/746 of the European Parliament and of the Council for in-vitro diagnostics, and DO NOT COMPLY WITH the requirements stipulated in Article 37, paragraph 1 of REGULATION No. 7 on the conditions and procedures for compiling the list of medical devices under Article 30a of the Medical Devices Act and for determining the value up to which they are paid.