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 – Annex No. 2 to the SWZ. The contract consists of 74 Packages. Partial tenders may be submitted for individual Packages (one or more); within each individual Package, a tender must be submitted for the full scope of the subject of the contract relating to that Package. The offered assortment must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. The Contractor will be bound by the tender until 09.09.2026 (90 days). The contract performance period is 12 months; performance of the contract will begin 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. 1 – Closed aspiration-vacuum or vacuum blood collection system; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 2 – Three-piece syringes, catheter-tip syringes, extension lines for infusion pumps, blood transfusion sets; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 3 – Needles, two-piece syringes, caps; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 4 – Drug administration sets – infusion pump; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 5 – Set for the preparation and administration of cytostatic drugs; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 6 – Syringes with 0.9% NaCl solution; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 7 – Catheters, drains; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 8 – Hygiene towels, gowns, blankets, duvets; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 9 – Endobronchial and endotracheal tubes; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 10 – Blades for a clipper; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. 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. 11 – Respiratory filters, urine-output measurement set, laryngeal masks; a detailed description of the subject of the contract, including the assortment and quantities, is specified in the assortment and price form – Annex 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 must have a shelf life of at least 6 months from the time the order is delivered to the Contracting Authority, unless a different shelf life is indicated in Annex 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), insofar as applicable. The offered medical devices should have the manufacturer’s EU declarations of conformity and, for device classes higher than Class I, certificates of conformity issued by a notified body authorised to certify under the MDR/MDD provisions. If the extended transitional period is used (invalid certificate, 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 pursuant to the transitional provisions: a statement on using 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 for assessment of the device’s conformity has been concluded with a notified body. 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 operations 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 Annex No. 2 to the SWZ – the assortment and price form; and in Annex No. 7 to the SWZ – the draft contract. Procedure: open. Review the original TED notice for the complete requirement, lots, amendments and attachments.