Guest user Created: Apr 01, 2022 Last commented: Apr 04, 2022
Qualifications of EU-rep from May 26th
Well it is implemented. The question with the toolkit I will discuss with our client. My main question is about the qualifications of the EU-rep from May 26th. As we interpretate the law you need an EU-rep following article 15 qualifications as the IVDD law is obsolete. This regardless of the extension period for IVDD devices on the market. Our UK counterpart says no, you don’t need a new EU-rep following IVDR qualifications for IVDD equipment which is still valid with IVDD certification. So we have a different point of view. We had some information from the UE which states lawfully you need a EU-rep following new IVDR/MDR regulations regardless the extension period for IVDD. For IVDD you follow the IVDD guidelines but as the regulation is obsolete from a legislative point of view you would need an EU-rep based on IVDR/MDR regulations (as IVDD/MDD regulations are not in force anymore but act as reference only). It would only make sense if the IVDD stays in force for IVDD equipment until the last IVDD is from the market. am curious on your opinion.
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Apr 01, 2022
Apr 04, 2022
Apr 04, 2022