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
- MDCG guidance documents on MDR codes and sampling of MDR and IVDR devices published
- Guidance document for class I device manufacturers
- Early access to Single Registration Numbers (SRN)
- New MDR and IVDR checklists for PMS and Declaration of Conformity
- News on symbols to be used under the MDR and IVDR
- Technical Documentation format under the MDR and IVDR
- News on EUDAMED
- DARE!! Services, bsi Netherlands and bsi UK designated under the MDR and IVDR
- Guidance on Qualification and Classification of Software under the MDR and IVDR Published
- New Notified Bodies Designated under the MDR and IVDR
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