Poland - Laboratory, optical and precision equipment (except glass)

Description

Before awarding the contract, the Awarding Entity will call upon the Economic Operator whose bid has been awarded the highest score to submit, within the set time limit, not shorter than 10 days, valid on the day of submission of the following statements or documents confirming the circumstances referred to in Article 25 paragraph 1 of the PPL:2 Act. In order to confirm that the offered deliveries meet the requirements specified by the contracting authority, i.e.: 1) Certificate of the entity authorized to quality control, confirming that the products delivered meet specific harmonised standards or technical specifications, in accordance with the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended), i.e.: 1) Certificate of the entity authorized to quality control, confirming that the products delivered meet specific harmonised standards or technical specifications, in accordance with the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended), i.e.:a) a document confirming that the product has been submitted to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, hereinafter referred to as the President of the Office, or a document confirming that the President of the Office has been notified of the introduction of a product intended for use in Poland; b) a certificate of conformity in cases specified in the Act on Medical Devices; c) a declaration of conformity confirming that the medical device complies with essential requirements; d) in the event that the subject of the order described in the ToR has not been classified as a medical device, the contracting authority requires the submission of an applied declaration confirming the contracting authority's requirements; e) a declaration of conformity confirming the requirements of the contracting authority; f) in the event that the subject of the order described in the ToR does not qualify as a medical device, the contracting authority requires the submission of an applied declaration confirming the contracting authority's requirements.Note: - If a document confirming the notification or notification to the President of the Office is issued for a medical device, the Contractor should submit only the document referred to in paragraph 1 point a of this Chapter, - If the document referred to in paragraph 1 point a is not issued for a medical device, the Contractor shall submit the document referred to in paragraph 1 point a, then the Contractor shall submit the document referred to in paragraph 1 point a of this Chapter, - If the document referred to in paragraph 1 point a of this Article is not issued for a medical device, the Contractor shall submit the document referred to in paragraph 1 point a of this Article. If for a medical device the document referred to in paragraph 1(b) of this Chapter is not issued, the economic operator shall submit the document referred to in paragraph 1(c) of this Chapter, - If for a medical device the document referred to in paragraph 1(c) is not issued, the economic operator shall submit the document referred to in paragraph 1(d) of this Chapter, in accordance with the subject matter of the contract.2) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, card, technical data form, etc.), confirming the technical and operational requirements contained in Annex 3 to the ToR (with an indication of the required parameters, part number and item number of the offered subject of the contract).3) Certificates, confirmations, statements, which are specified in detail in Annex 3 to the ToR - according to the subject of the contract. Before awarding the contract, the Awarding Entity will call upon the Economic Operator whose bid has been awarded the highest score to submit, within the set time limit, not shorter than 10 days, valid on the day of submission of the following statements or documents confirming the circumstances referred to in Article 25 paragraph 1 of the PPL:2 Act. In order to confirm that the offered deliveries meet the requirements specified by the contracting authority, i.e.: 1) Certificate of the entity authorized to quality control, confirming that the products delivered meet specific harmonised standards or technical specifications, in accordance with the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended), i.e.:a) a document confirming that the product has been submitted to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, hereinafter referred to as the President of the Office, or a document confirming that the President of the Office has been notified of the introduction of a product intended for use in Poland; b) a certificate of conformity in cases specified in the Act on Medical Devices; c) a declaration of conformity confirming that the medical device complies with essential requirements; d) in the event that the subject of the order described in the ToR has not been classified as a medical device, the contracting authority requires the submission of an applied declaration confirming the contracting authority's requirements; e) a declaration of conformity confirming the requirements of the contracting authority; f) in the event that the subject of the order described in the ToR does not qualify as a medical device, the contracting authority requires the submission of an applied declaration confirming the contracting authority's requirements.Note: - If a document confirming the notification or notification to the President of the Office is issued for a medical device, the Contractor should submit only the document referred to in paragraph 1 point a of this Chapter, - If the document referred to in paragraph 1 point a is not issued for a medical device, the Contractor shall submit the document referred to in paragraph 1 point a, then the Contractor shall submit the document referred to in paragraph 1 point a of this Chapter, - If the document referred to in paragraph 1 point a of this Article is not issued for a medical device, the Contractor shall submit the document referred to in paragraph 1 point a of this Article. If for a medical device the document referred to in paragraph 1(b) of this Chapter is not issued, the economic operator shall submit the document referred to in paragraph 1(c) of this Chapter, - If for a medical device the document referred to in paragraph 1(c) is not issued, the economic operator shall submit the document referred to in paragraph 1(d) of this Chapter, in accordance with the subject matter of the contract.2) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, card, technical data form, etc.), confirming the technical and operational requirements included in Annex 3 to the ToR (with an indication of the required parameters, part number and item number of the offered subject of the contract).3) Certificates, confirmations, statements, which are specified in detail in Annex 3 to the ToR - according to the subject of the contract. Before awarding the contract, the Awarding Entity will call upon the Economic Operator whose bid has been awarded the highest score to submit, within the set time limit, not shorter than 10 days, valid on the day of submission of the following statements or documents confirming the circumstances referred to in Article 25 paragraph 1 of the PPL:2 Act. In order to confirm that the offered deliveries meet the requirements specified by the contracting authority, i.e.: 1) Certificate of the entity authorized to quality control, confirming that the products delivered meet specific harmonised standards or technical specifications, in accordance with the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended), i.e.: 1) Certificate of the entity authorized to quality control, confirming that the products delivered meet specific harmonised standards or technical specifications, in accordance with the Act of 20.5.2010 on Medical Devices (Journal of Laws of 2019, item 175, as amended), i.e.:a) a document confirming that the product has been submitted to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, hereinafter referred to as the President of the Office, or a document confirming that the President of the Office has been notified of the introduction of a product intended for use in Poland; b) a certificate of conformity in cases specified in the Act on Medical Devices; c) a declaration of conformity confirming that the medical device complies with essential requirements; d) in the event that the subject of the order described in the ToR has not been classified as a medical device, the contracting authority requires the submission of an applied declaration confirming the contracting authority's requirements; e) a declaration of conformity confirming the requirements of the contracting authority; f) in the event that the subject of the order described in the ToR does not qualify as a medical device, the contracting authority requires the submission of an applied declaration confirming the contracting authority's requirements.Note: - If a document confirming the notification or notification to the President of the Office is issued for a medical device, the Contractor should submit only the document referred to in paragraph 1 point a of this Chapter, - If the document referred to in paragraph 1 point a is not issued for a medical device, the Contractor shall submit the document referred to in paragraph 1 point a, then the Contractor shall submit the document referred to in paragraph 1 point a of this Chapter, - If the document referred to in paragraph 1 point a of this Article is not issued for a medical device, the Contractor shall submit the document referred to in paragraph 1 point a of this Article. If for a medical device the document referred to in paragraph 1(b) of this Chapter is not issued, the economic operator shall submit the document referred to in paragraph 1(c) of this Chapter, - If for a medical device the document referred to in paragraph 1(c) is not issued, the economic operator shall submit the document referred to in paragraph 1(d) of this Chapter, in accordance with the subject matter of the contract.2) Information materials containing a description of the offered subject of the contract (prospectus, catalogue, card, technical data form, etc.), confirming the technical and operational requirements included in Annex 3 to the ToR (with an indication of the required parameters, part number and item number of the offered subject of the contract).3) Certificates, confirmations, statements, which are specified in detail in Annex 3 to the ToR - according to the subject of the contract.

Opportunity closing date

17 January 2020

Value of contract

£100k-1m