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, has been 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 several); 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 min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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, 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. 12 - Nebulisers; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 13 - Mask with nebuliser; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 14 - Wash mitts and other disposable patient hygiene materials; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 15 - Surgical films, warming blankets; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 16 - Underpads; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 17 - Sets, surgical-field drapes, cable covers; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 18 - Sets, instruments for medical procedures; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 19 - Masks, ventilator breathing circuit, anaesthetic circuit; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 20 - Venous catheterisation set, anaesthesia set; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 21 - Set for collecting secretions and aspirating effusions; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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. 22 - Diathermy assortment; a detailed description of the subject of the contract, including the assortment and quantities, has been 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 is required to have an expiry date of min. 6 months from the time the order is delivered to the Contracting Authority, unless a different expiry period has been 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 to them. 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 perform certification under the MDR/MDD provisions. Where the extended transitional period is used (invalid certificate, certificate issued under the “old” directives: 90/385/EEC or Directive 93/42/EEC), due to the need to confirm that the offered medical device may be placed on the market pursuant to the transitional provisions, a declaration concerning use of the transitional period, the manufacturer's own 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 have been specified in Chapter II of the SWZ, section 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.