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 range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 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 under Package No. 55 – Breathing circuits, cannulas; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 56 – Ventilation circuits, NIV/CPAP masks; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 57 – Suction valves for an ultrasonic bronchofiberscope; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 58 – Cryobiopsy equipment compatible/equivalent with ERBECRYO 2; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 59 – Suction catheters, probe covers; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 60 – Accessories for thyroid neuromonitoring; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 61 – Disposable pressure manometer; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 62 – Huber port needles, tubing and closed-system infusion sets, blades, surgical scalpels; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 63 – Safety cannulas, caps for safety cannulas, fluid administration devices; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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 under Package No. 64 – Vascular port; a detailed description of the subject of the contract, including the range and quantities, has been specified in the assortment and pricing 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 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 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), to the extent 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 provide certification 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 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 of the conclusion of an agreement with a notified body for conformity assessment of the device. The offered devices must bear the CE mark, 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 set out in Chapter II of the SWZ, section 1, Subject of the contract; in Annex No. 2 to the SWZ—the assortment and pricing 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.