Poland - Medical devices

Description

Purchase of medical equipment and apparatus for the Specialist Hospital in Zabrze Sp. z o.o.; Case No. DZP/31 PN/2023Detailed description of the subject matter of the order constitutes attachment No. 3 to the SWZ - description of technical parameters (separately for each Package).The subject matter of the order is divided into 3 Packages:Package No. 1: Operating tables x 2 pieces.Package No. 2: Operating table x 1 item.Package No. 3: Operating microscope x 1 item.Whenever in the content of the SWZ, as far as the description of the subject matter is concerned, reference is made to a type/trademark, origin, etc., it is assumed that such indication is accompanied by the word "or equivalent". The Purchaser will consider equivalent equipment to be that which has the same or better technical and quality parameters than those described in the SWZ, and its use will in no way affect the proper functioning of the assortment as intended.
Package No. 1: Operating tables x 2 pcs.Detailed description of the subject of the contract is attached as Annex No. 3 to the SWZ - technical parameters.Contractors submitting an offer in the proceedings declare that they undertake to comply with the following requirements:1) They will offer equipment consistent with the description of the subject of the contract - technical parameters.2) They will offer complete equipment, brand new, no post-issue, year of manufacture no earlier than 2023.3) They will provide at their own expense and risk transport of equipment to the headquarters of the Employer and unloading and internal transport to the place indicated by the Employer and installation. The Contractor, after installation of the subject matter of the contract, will take all transport and other packaging provided and not required to be retained by the Ordering Party for possible warranty actions.4) Offer the subject matter of the contract, which meets the requirements specified in:- The Law on Medical Devices of 07 April 2022 (Journal of Laws of 2022, item 974)- Ordinance of the Minister of Health of November 5, 2010 on how to classify medical devices (Journal of Laws of 2010, No. 215, item 1416),- Ordinance of the Minister of Health of February 17, 2016 on essential requirements and conformity procedures of medical devices (Journal of Laws of 2016, item 211),- Regulation of the European Parliament and of the Council (EU) 2019/1020 of June 20, 2019 on market surveillance and product conformity - to the extent applicable,- Announcement of the President of the Polish Committee for Standardization of August 9, 2019 on harmonized standards (M.P. of 2019, Item 940),- Council Directive 93/42/EEC of June 14, 1993 concerning medical devices (U.E.L.1993, item 169.1 as amended),- Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (U.E.L.20172017, item 117.1 as amended)5) Transport of all medical devices will be carried out in accordance with the requirements provided for in the current documents confirming approval of the subject of the order for marketing and use in accordance with the Law of 07.04.2022 on medical devices. In accordance with the EU Regulation (EU) 2017/745 (MDR Regulation), the distributor of medical devices is obliged to store and transport in accordance with the conditions specified by the manufacturer.6) They will sign a contract, the template of which is attached as Annex No. 4 to the SWZ 7) They will offer a minimum warranty period: min. 36 months from the date of signing the protocol of acceptance of the equipment - for Package No. 1.8) They will provide training to the Hospital staff in the use of the offered product (equipment).Other requirements in accordance with Chapter III item. 3 SWZ. Package No. 2: Operating lamp x 1 item.Detailed description of the subject matter of the contract is attached as Annex No. 3 to the SWZ - technical parameters.Contractors submitting a bid in the proceedings declare that they undertake to comply with the following requirements:1) They will offer equipment consistent with the description of the subject matter of the contract - technical parameters.2) They will offer complete equipment, brand new, no post-issue, the year of production not earlier than 2023.3) They will provide at their own expense and risk transport of equipment to the headquarters of the Employer and unloading and internal transport to the place indicated by the Employer and installation. The Contractor, after installation of the subject matter of the contract, will take all transport and other packaging provided and not required to be retained by the Ordering Party for possible warranty actions.4) Offer the subject matter of the contract, which meets the requirements specified in:- The Law on Medical Devices of 07 April 2022 (Journal of Laws of 2022, item 974)- Ordinance of the Minister of Health of November 5, 2010 on how to classify medical devices (Journal of Laws of 2010, No. 215, item 1416),- Ordinance of the Minister of Health of February 17, 2016 on essential requirements and conformity procedures of medical devices (Journal of Laws of 2016, item 211),- Regulation of the European Parliament and of the Council (EU) 2019/1020 of June 20, 2019 on market surveillance and product conformity - to the extent applicable,- Announcement of the President of the Polish Committee for Standardization of August 9, 2019 on harmonized standards (M.P. of 2019, Item 940),- Council Directive 93/42/EEC of June 14, 1993 concerning medical devices (U.E.L.1993, item 169.1 as amended),- Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (U.E.L.20172017, item 117.1 as amended)5) Transport of all medical devices will be carried out in accordance with the requirements provided for in the current documents confirming approval of the subject of the order for marketing and use in accordance with the Law of 07.04.2022 on medical devices. In accordance with the EU Regulation (EU) 2017/745 (MDR Regulation), the distributor of medical devices is obliged to store and transport in accordance with the conditions specified by the manufacturer.6) They will sign a contract, the template of which is attached as Annex No. 4 to the SWZ 7) They will offer a minimum warranty period: min. 36 months from the date of signing the protocol of acceptance of the equipment - for Package No. 2.8) They will provide training to the Hospital staff in the use of the offered product (equipment).9) For Package No. 2 - operating lamp, the Contractor is obliged to dismantle the operating lamp of the Purchaser and dispose of it in accordance with applicable regulations. Any changes (damage) resulting from the need to dismantle the current lamp and install the subject of the contract in the building infrastructure of the Ordering Party's operating room, remove at his own expense and risk and bring it to a condition no worse than before he took his actions. 10) In order to properly execute in Package No. 2 of the contract, the Contracting Authority will allow Contractors to familiarize themselves with the condition and type of infrastructure of the Operating Room. In this regard, the Contracting Authority shall schedule a site visit. Participation in the site visit is not an obligatory requirement and will not result in rejection of the bid on the basis of Article 226 paragraph 1 item. 18 of the PPL.Other requirements in accordance with Chapter III, item. 3 SWZ. A detailed description of the subject matter of the contract is attached as Appendix No. 3 to the SWZ - technical parameters.Contractors submitting an offer in the proceedings declare that they undertake to comply with the following requirements:1) They will offer equipment consistent with the description of the subject matter of the contract - technical parameters.2) They will offer complete equipment, brand new, not post-issue, year of production no earlier than 2023.3) They will provide at their own expense and risk transport of equipment to the headquarters of the Employer and unloading and internal transport to the place indicated by the Employer and installation. The Contractor, after installation of the subject matter of the contract, will take all transport and other packaging provided and not required to be retained by the Ordering Party for possible warranty actions.4) Offer the subject matter of the contract, which meets the requirements specified in:- The Law on Medical Devices of 07 April 2022 (Journal of Laws of 2022, item 974)- Ordinance of the Minister of Health of November 5, 2010 on how to classify medical devices (Journal of Laws of 2010, No. 215, item 1416),- Ordinance of the Minister of Health of February 17, 2016 on essential requirements and conformity procedures of medical devices (Journal of Laws of 2016, item 211),- Regulation of the European Parliament and of the Council (EU) 2019/1020 of June 20, 2019 on market surveillance and product conformity - to the extent applicable,- Announcement of the President of the Polish Committee for Standardization of August 9, 2019 on harmonized standards (M.P. of 2019, Item 940),- Council Directive 93/42/EEC of June 14, 1993 concerning medical devices (U.E.L.1993, item 169.1 as amended),- Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (U.E.L.20172017, item 117.1 as amended)5) Transport of all medical devices will be carried out in accordance with the requirements provided for in the current documents confirming approval of the subject of the order for marketing and use in accordance with the Law of 07.04.2022 on medical devices. In accordance with the EU Regulation (EU) 2017/745 (MDR Regulation), the distributor of medical devices is obliged to store and transport in accordance with the conditions specified by the manufacturer.6) They will sign a contract, the template of which is attached as Annex No. 4 to the SWZ 7) They will offer a minimum warranty period: min. 24 months from the date of signing the protocol of acceptance of the equipment - for Package No. 3.8) They will provide training to the Hospital staff in the use of the offered product (equipment).Other requirements in accordance with Chapter III item. 3 OF THE SWZ.

Opportunity closing date

03 November 2023

Value of contract

to be confirmed