Poland - Medical devices

Description

The contract includes: Specialist apparatus: 1 - Video laryngoscopes - 1 pcs. 2 - Bronchofibroscope - 1 pcs. A detailed description of the subject of the contract is included in the Quotation Form - Appendix No. 1 to the ToR for Part 1. The offered subject of the contract must meet the requirements specified in the Terms of Reference: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, Ordinance of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416) Ordinance of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211) Ordinance of the Minister of Health of 17 February 2016 on the method of submission of notifications and notifications concerning devices (Journal of Laws of 2016, No. 159, item 1416), Regulation of the Minister of Health of 22.9.2010 on the model CE mark (Journal of Laws 2010, No. 186, item 1252) Regulation of the Minister of Development and Finance of 21.12.2016 on the essential requirements concerning the restriction of the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7) Directive 93/42/EEC of 14.4.1993. - Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011) Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Article 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Contracting Authority together with the supply of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Devices which are not medical devices and which do not require registration in the Register of Medicinal Products, Medical Devices and Biocidal Products, must have the documents required by law authorising their marketing and use on the territory of Poland, and be marked with the CE mark. The order includes: a) Anaesthesia ultrasound apparatus - 1 pc. b) Doppler ultrasound apparatus - 1 pc. A detailed description of the subject of the contract is included in the Quotation Form - Appendix No. 1 to the ToR for Part 1. The offered subject of the contract must meet the requirements specified in the Terms of Reference: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, Ordinance of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416) Ordinance of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211) Ordinance of the Minister of Health of 17 February 2016 on the method of submission of notifications and notifications concerning devices (Journal of Laws of 2016, No. 159, item 1416), Regulation of the Minister of Health of 22.9.2010 on the model CE mark (Journal of Laws 2010, No. 186, item 1252) Regulation of the Minister of Development and Finance of 21.12.2016 on the essential requirements concerning the restriction of the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7) Directive 93/42/EEC of 14.4.1993. - Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011) Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Article 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Contracting Authority together with the supply of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Devices which are not medical devices and which do not require registration in the Register of Medicinal Products, Medical Devices and Biocidal Products, must have the documents required by law authorising their marketing and use on the territory of Poland, and be marked with the CE mark. The order includes: a) X-ray screen - 1 pc. b) Bedside X-ray apparatus - 1 pc. A detailed description of the subject of the contract is included in the Quotation Form - Appendix No. 1 to the ToR for Part 1. The offered subject of the contract must meet the requirements specified in the Terms of Reference: Act of 20.5.2010 on medical devices (Journal of Laws of 2015, Ordinance of the Minister of Health of 5 November 2010 on the method of qualification of medical devices (Journal of Laws of 2010, No. 215, item 1416) Ordinance of the Minister of Health of 17 February 2016 on essential requirements and conformity assessment procedures for medical devices (Journal of Laws 2016, item 211) Ordinance of the Minister of Health of 17 February 2016 on the method of submission of notifications and notifications concerning devices (Journal of Laws of 2016, No. 159, item 1416), Regulation of the Minister of Health of 22.9.2010 on the model CE mark (Journal of Laws 2010, No. 186, item 1252) Regulation of the Minister of Development and Finance of 21.12.2016 on the essential requirements concerning the restriction of the use of certain hazardous substances in electrical and electronic equipment (Journal of Laws 2017.7) Directive 93/42/EEC of 14.4.1993. - Directive 2007/47/EC of 21.9.2007 amending Directive 93/42/EEC of 14.4.1993. - concerning medical devices Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (Official Journal of the European Union 1.7.2011) Declaration of conformity or CE certificate (if applicable) confirming that the device meets the essential requirements referred to in Article 23 (1) of the Act on Medical Devices: a document confirming the current admission to the market of offered products, i.e. medical equipment and devices being the subject of this procedure, shall be provided to the Contracting Authority together with the supply of medical equipment and devices. All documents must be valid in accordance with Article 10.1 of the Act on Medical Devices and Article 94.1 of the Act on Medical Devices. Devices which are not medical devices and which do not require registration in the Register of Medicinal Products, Medical Devices and Biocidal Products, must have the documents required by law authorising their marketing and use on the territory of Poland, and be marked with the CE mark.

Opportunity closing date

21 January 2019

Value of contract

£100k-1m