We are specify the Tender Terms of the purchase for Services of CE certification of 11 medical devices
5 APRIL 2016
1. We are specify the Tender Terms of the purchase for Services of CE certification of 11 medical devices (testing of physical and biological properties of dental materials).
Download the Tender terms.
2. In according to Tender Terms we respond to written requests that explain the Tender Terms.
Question: Potential participant can‘t find term of delivery and asks: what is the time schedule of the testing?
Answer: The Supplier shall submit the Term of performance (in days) in the form provided in Annex 2 (Proposition).
Question: Potential participant asks: Could the term (April 15th) be prolonged?
Answer: The term is prolonged. The proposition shall be submitted by 3.00 p.m. on 22th April 2016 Lithuanian time (p. 4.9. in Tender Terms).
Question: Potential participant requests to fill in additional Device Questionnaires.
Answer: Participant should provide Proposition on the basis of Technical Specifications. No additional Questionnaires will be completed.
7 APRIL 2016 – update:
Question: Do we have to offer all the testing listed in the document (Technical Specification)?
Answer: Supplier can submit a Proposition for each part/several parts/all parts of purchase (p.2.2; p.4.7 of Tender Terms).
Question: Are the requested tests the result of a biological risk assessment from your side?
Question: Would you have more information regarding each product? (IFU, composition, etc.)?
Answer: No. All product-specific information will be provided to Supplier after Contract is signed.
Question: Could you please precise what “repeated” means?
Answer: Kindly please refer EN ISO 10993-11:2013 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity (ISO 10993-11:2006).
Question: Would you be available for a call in order to discuss the following different points?
Answer: All questions and communicating is possible in written (by e-mail) during the Tender. All official answers to your questions will be published here in our website.
Question: Should we provide the price without VAT?
Answer: Yes. Please state the final price in column “EUR (w/o VAT)” and repeat it in the column “EUR (incl. VAT)” as VAT is not applicable for the laboratory services.
14 APRIL 2016 – update:
Question: Please advise us of what is meant on Stability in the document Annex No.1 Technical specification.
Answer: Stability study – short-term (accelerated) stability study to justify the shelf life of medical devices.
18 APRIL 2016 – update:
Question: Do we fill in the column “GLP test price” for the test methods for which we hold accreditation according to ISO 17025? As well, for any test methods without specific accreditation, do we fill in the column “Non GLP test price”?
Answer: If the requirement (http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice/index_en.htm) to conduct tests according to the principles of Good Laboratory Practice (GLP) is applicable for specific test, then please indicate “GLP test price” and “Non GLP test price”. If this requirement is not applicable, then please state in the column “GLP test price” – “Non applicable”.
Regarding test methods without specific accreditation – kindly please in the column “Applicable standard and method” by applicable standard or method, indicate which test methods are non accredited.