And it will provide insight into the requirements for Periodic Safety Update Reports and for Summary of Safety and Clinical Performance that will be part of the growing technical documentation for the products over its lifetime.
It will clarify the approaches and extent of data collection in the post-market phase. It clarifies what is needed for annex II technical documentation that needs to be ready (and reviewed by Notified Bodies as appropriate) before the market introduction of the new product. This training focusses on practical guidance to fulfill the technical documentation requirements in the EU-MDR. With all the changes one can only conclude that all technical files and design dossiers need to be revised to match the EU-MDR requirements. It differentiates between data needed prior to market access (MDR annex II) and post market data (annex III). The EU-MDR introduces a new view on technical documentation, that is broader than the current view on technical files and design dossiers (class III). Transfer of Technical File, CE Mark etc.Language: Presentations will be in English If anyone has interest in a particular section, let me know (via email) and I'll provide a copy (redacted as needed).ĬE Mark - Maintaining Technical File and Regulatory AssessmentĬE Marking (Conformité Européene) / CB Scheme I have attached these as references if anyone is interested. In the printed version, it is simply blue underlined text indicating the same structure.īoth Part A & B contain a table of contents in line with the NB-MED/2.5.1/Rec 5. In the electronic version of Part B, this is a live hyperlink. Then, I added the statement: "Current revisions of all documents in Part B of thei Technical File may are maaintained on the ABC Company controlled acccess server and may be accessed at: g\document\qualitysystem\technical file". QM-12345-XXX, where XXX was the revision level reference. For example, documents reverenced in Part B would NOT contain the revision level, e.g. This avoided two major issues: printing out TONS of technical data, validations, etc., and (more significantly) eliminating the need to physically remove and replace pages when documents are revised. Since this does NOT need to reside in the EU with the AR, it contains many links to live documents on our server. The only big single item was a print-out (2 sided) of a 125 page user manual. Since most of Part A informatiuon is "summary" type information, this worked well. As recommended, I divided it into two parts: A & B.īecause Part A needs to go to the Authorized Representative (AR) in Europe, it is all "hard copy", meaning no links to documents on our server. I JUST completed our Technical File (TF) for a Class IIb product. Re: Technical File for CE declaration - Template or Sample of required contents
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