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 on administrative practices and technical alternatives until EUDAMED full functionality
- Approval for COVID-19 rapid antigen tests intended for self-testing by lay persons
- European Commission publishes Q&A guidance on COVID-19 tests
- Voluntary registration with EUDAMED database – industry fears duplicate registrations
- Additional MHRA guidance for medical device companies
- mdi Europa experience on MDR technical documentation reviews
- BfArM informs about damages to hip implants
- EU IVD medical devices sector destined for crisis?
- Sufficient clinical evidence under the MDR for class I legacy devices
- New website on actor registration in EUDAMED 3 available
Browse our complete range of articles by keyword
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