The subject of the contract is the successive delivery of reagent kits for the control of newborn screening for congenital metabolic defects. A detailed description and method of order execution are included in the assortment and price table of Appendix No. 2 to the Terms of Use and a model agreement attached No. 4 to the Terms of Reference. The deadline for the completion of the subject of the contract is 24 months 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 does not allow for the submission of partial bids. The Contracting Authority does not provide for the possibility of awarding contracts referred to in Article 214(1)(8).

The subject of the contract is the successive delivery of reagent kits for the control of newborn screening for congenital metabolic defects. A detailed description and method of order execution are included in the assortment and price table of Appendix No. 2 to the Terms of Use and a model agreement attached No. 4 to the Terms of Reference.

1. The Contracting Authority shall request the submission with the tender under the rigour of annulment in electronic form of the following measures of evidence in question to confirm that the deliveries offered meet the requirements laid down by the Contracting Authority:

1) A current document proving:

• approval of marketing and use as a medical device meeting the requirements within the meaning of the Act of 7.04.2022 on medical devices (Journal of Laws of 2022, item 974),

• compliance with Regulation (EU) 2017/745 of the European Parliament and of the Council on Medical Devices (MDR) / (EU) 2017/46 on in vitro medical devices, with the CE-IVD marking of the device,

- i.e. declaration of conformity / certificate of conformity issued by the manufacturer or an authorized/authorized representative, in the scope of marking the product with the CE-IVD mark, another document (catalogue, card, etc.) confirming the indicated marking is allowed.

2) Contractor's statement confirming that the offered assortment is approved for trading and use as a medical device in Polish.

3) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, card, data form, etc.), confirming the requirements contained in Appendix No. 2 to the Terms of Reference (with the required parameters indicated).

4) A contractor offering products equivalent to the products described in the procedure in question is obliged to:

• Demonstrate on the basis of technical documentation/safety data sheets, reagents/etc. and a written declaration that the equivalent products offered by the Contracting Authority meet the requirements allowing for the continuation of the Contracting Authority's scientific research without the need to perform additional activities (procedures), including, for example, calibration of equipment, validation of developed laboratory methods;

• demonstrate (by means of a written declaration in the bid) that the equivalent products offered will not result in an increase in costs due to the need to purchase additional products and other consumables;

• accept – in the form of a written declaration – responsibility for damage to the equipment resulting from the use of the equivalent products offered and supplied, on the basis of an opinion issued by the equipment manufacturer's authorized service provider.

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