The subject of the order is the delivery of a set of mass spectrometer with liquid chromatograph, semi-automatic cutting machines and a vacuum concentrator. A detailed description and method of execution of the order is contained in the assortment and price table of Appendix No. 2 to the Terms of Reference, the description of the subject matter of the contract (OPZ) constituting Appendix No. 3 to the Terms of Reference and the model agreement attached No. 4 to the Terms of Reference. Required deadline for completion of the subject of the contract: by 27 December 2023 from the date of conclusion of the contract. The Contracting Authority declares that being a data controller and taking into account the provisions of the Act of 10.05.2018 on the protection of personal data (hereinafter referred to as GDPR), it has implemented security measures adequate to the risks identified by it and providing a guarantee of proper protection of personal data transferred as part of the procedure. Detailed info clause. Article 13 of the GDPR contained in the Terms of Reference. The Contracting Authority does not require the payment of a bid bond. The Contracting Authority allows for the possibility of submitting partial offers divided into 3 lots.

The subject of the contract is the delivery of a mass spectrometer set with a liquid chromatograph. A detailed description and method of execution of the order is contained in the assortment and price table of Appendix No. 2 to the Terms of Reference, the description of the subject matter of the contract (OPZ) constituting Appendix No. 3 to the Terms of Reference and the model agreement attached No. 4 to the Terms of Reference.

1. The Ordering Party requests that together with the offer, under pain of nullity in electronic form, the following means of proof be submitted to confirm that the offered deliveries meet the requirements specified by the Ordering Party:

1) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Appendix No. 3 to the Terms of Use – excluding the conditions "warranty and service conditions, other requirements" (with the indication of the required parameters, the position of the offered subject of the contract).

2) Current documents and statements confirming marketing authorization and for use as a medical device that meets the requirements within the meaning of the Act of 07 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), i.e.

(a)a declaration/certificate of conformity (issued by the manufacturer or an authorised representative) confirming that the product complies with the essential requirements;

b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in Polish;

(c)a document attesting to the conformity assessment procedure with the notified body (certificate of the notified body), if applicable

or:

Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading and use in the Polish in accordance with applicable regulations if the subject of the contract described in the SWZ has not been classified as a medical device.

2.If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for their submission or supplement within the time limit set.

The subject of the contract is performed as part of the health policy entitled Government Newborn Screening Program in Poland for 2019-2026 – Agreement No. 8/2/2023/106/277.

The subject of the order is the supply of semi-automatic cutting machines. A detailed description and method of execution of the order is contained in the assortment and price table of Appendix No. 2 to the Terms of Reference, the description of the subject matter of the contract (OPZ) constituting Appendix No. 3 to the Terms of Reference and the model agreement attached No. 4 to the Terms of Reference.

1. The Ordering Party requests that together with the offer, under pain of nullity in electronic form, the following means of proof be submitted to confirm that the offered deliveries meet the requirements specified by the Ordering Party:

1) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Appendix No. 3 to the Terms of Use – excluding the conditions "warranty and service conditions, other requirements" (with the indication of the required parameters, the position of the offered subject of the contract).

2) Current documents and statements confirming marketing authorization and for use as a medical device that meets the requirements within the meaning of the Act of 07 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), i.e.

(a)a declaration/certificate of conformity (issued by the manufacturer or an authorised representative) confirming that the product complies with the essential requirements;

b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in Polish;

(c)a document attesting to the conformity assessment procedure with the notified body (certificate of the notified body), if applicable

or:

Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading and use in the Polish in accordance with applicable regulations if the subject of the contract described in the SWZ has not been classified as a medical device.

2.If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for their submission or supplement within the time limit set.

The subject of the contract is performed as part of the health policy entitled Government Newborn Screening Program in Poland for 2019-2026 – Agreement No. 8/2/2023/106/277.

The subject of the contract is the supply of a vacuum concentrator. A detailed description and method of execution of the order is contained in the assortment and price table of Appendix No. 2 to the Terms of Reference, the description of the subject matter of the contract (OPZ) constituting Appendix No. 3 to the Terms of Reference and the model agreement attached No. 4 to the Terms of Reference.

1. The Ordering Party requests that together with the offer, under pain of nullity in electronic form, the following means of proof be submitted to confirm that the offered deliveries meet the requirements specified by the Ordering Party:

1) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, leaflet, technical data sheet issued by the manufacturer of the product, etc.), confirming the requirements contained in Appendix No. 3 to the Terms of Use – excluding the conditions "warranty and service conditions, other requirements" (with the indication of the required parameters, the position of the offered subject of the contract).

2) Current documents and statements confirming marketing authorization and for use as a medical device that meets the requirements within the meaning of the Act of 07 April 2022 on medical devices (i.e. Journal of Laws of 2022, item 974), i.e.

(a)a declaration/certificate of conformity (issued by the manufacturer or an authorised representative) confirming that the product complies with the essential requirements;

b) the Contractor's statement confirming that the offered assortment is approved for marketing and use as a medical device in Polish;

(c)a document attesting to the conformity assessment procedure with the notified body (certificate of the notified body), if applicable

or:

Contractor's statement confirming that the offered products meet the requirements specified by the Ordering Party and are admitted to trading and use in the Polish in accordance with applicable regulations if the subject of the contract described in the SWZ has not been classified as a medical device.

2.If the Contractor does not submit the measures of evidence in question or the measures in question are incomplete, the Contracting Authority shall call for their submission or supplement within the time limit set.

The subject of the contract is performed as part of the health policy entitled Government Newborn Screening Program in Poland for 2019-2026 – Agreement No. 8/2/2023/106/277.