Poland – Disposable non-chemical medical consumables and haematological consumables – Supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra

Opportunity description

The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. The contract consists of 74 Packages. Partial tenders may be submitted for individual Packages (one or more); within each Package, a tender must be submitted for the full scope of the subject of the contract relating to that Package. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The Contractor will be bound by the tender until 09.09.2026 (90 days). The contract performance period is 12 months; performance of the agreement will commence no earlier than 07.07.2025 for Packages Nos. 1, 4-5, 8-9, 11-15, 17, 18, 21-24, 26-28, 30, 34, 38, 40-41, 46, 48-49, 52-53, 55-56, 58, 60, 62-66, 69, 72-74; from 10.07.2026 for Packages Nos. 10, 20, 25, 43, 50, 59; from 16.07.2026 for Packages Nos. 2, 3, 29, 31-33, 35, 42, 44-45, 51, 54, 67; from 16.07.2026 for Packages Nos. 7, 16, 19, 37, 39, 47; and from 21.07.2026 for Packages Nos. 6, 36, 57, 61, 68, 70-71. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 34 – Cutaneous and rectal-oesophageal temperature sensors; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 35 – CO2 sensors; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 36 – Nasal cannula; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 37 – Capillary tubes and caps for the blood gas analyser; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 38 – Biopsy needles, brushes, forceps; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 39 – Haemodynamic monitoring equipment compatible/equivalent with Picco equipment, brushes, forceps; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 40 – Tracheotomy sets, Heimlich valves, safe pleural puncture sets, brushes, forceps; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 41 – Invasive pressure measurement set; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 42 – Antibacterial/antiviral filter; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 43 – Catheters, CRRT procedure sets, Chemo devices; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. The subject of the contract is the supply of disposable medical devices for the needs of the Centre for Pulmonology and Thoracic Surgery in Bystra within Package No. 44 – Bowls, bedpans, urinals made of cellulose pulp; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Appendix No. 2 to the SWZ. Within the Package, a tender must be submitted for the full scope of the subject of the contract. The offered assortment is required to have an expiry date of at least 6 months from the moment the order is delivered to the Contracting Authority, unless a different expiry period is specified in Appendix No. 2 to the SWZ. The Contracting Authority requires the entire assortment to be new and unused. All offered medical materials that are medical devices must be placed on the market and put into use in the territory of the Republic of Poland and classified in accordance with the applicable provisions of: EU Regulation 2017/745 on medical devices, EU Regulation 2017/746 on in vitro diagnostic medical devices, and the Act of 7.04.2022 on medical devices (consolidated text: Journal of Laws 2024, item 1620), to the extent applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, in the case of device classes higher than Class I, certificates of conformity issued by a notified body authorised to perform certification under the MDR/MDD provisions. Where the extended transitional period is used (an invalid certificate, a certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), in connection with the need to confirm that the offered medical device may be placed on the market under the transitional provisions, a declaration on the use of the transitional period, the manufacturer’s self-declaration specifying the end date of the transitional period, the manufacturer’s quality management system certificate, and confirmation that an agreement has been concluded with a notified body for the conformity assessment of the device. The offered devices must bear the CE marking, have instructions for use in Polish, and be marked with the name/trade name or registered trademark and the address of the manufacturer’s registered place of business. If the registered place of manufacturing activity is outside the EU, they must bear the name of the authorised representative and the address of its registered place of business. The requirements concerning the subject of the contract are specified in Chapter II of the SWZ, paragraph 1, Subject of the contract; in Appendix No. 2 to the SWZ – the assortment and price form; and in Appendix No. 7 to the SWZ – the draft agreement. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.