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Qualifications of EU-rep from May 26th

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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 As we interpretate the law you need an EU-rep following article 15 qualifications as the IVDD law is obsolete.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 For IVDD you follow the IVDD guidelines but as the regulation is obsolete from a legislative point of view you would need an EU-rep based on IVDR/MDR regulations (as IVDD/MDD regulations are not in force anymore but act as reference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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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Apr 04, 2022

Yes, you are correct. You must have an EU rep according to the requirements from the IVDR when you will be ready for the certification with IVDR. For more details please see Article 110 from the IVDR 2017/746 Transitional provisions. There is stated that the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, and registration of economic operators, and devices shall apply and replace the corresponding requirements in that Directive 98/79/EC.

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