This section provides relevant news on the (European) regulatory environment for medical devices. You may browse the articles by the following overview of the 10 latest topics or by selecting your topic of interest in the keyword section further below. The news and articles published on this website are presented in a condensed form. You may access our full-scale service when engaging mdi Europa as your EU Authorized Representative.
Browse our “News in Brief” section by 10 newest articles
- bsi develops guidelines for the application of ISO 14971 to artificial intelligence and machine learning
- The IVDR and performance evaluation studies
- New MDCG guidance document maps IMDRF UDI principles with MDR and IVDR
- Insufficient sterilization of medical devices by Steril Milano S.r.l
- Guidance documents on clinical investigation applications, UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers, implant cards and EMDN
- EU UDI helpdesk available
- Standard ISO 20417:2021 for the MDR and IVDR published
- Guidance document on the impact of genetic variants on SARS-COV-2
- EU clearance for MDR and IVDR harmonised standards
- EU – Switzerland MRA expired
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