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
- EUDAMED update on timelines
- Ukraine tries to maintain business as usual
- New cybersecurity standard
- IVD medical devices after the IVDR date of application
- New guidance for notified bodies of MDD/ AIMDD legacy device certificates and IVDR class D devices
- EN ISO 13485 and symbols standards harmonised under the EU’s IVDR
- MDR harmonised standards update
- New guidance for third-country manufacturers of COVID-19 IVD tests
- IVDR clinical evidence
- elFU rules under the EU‘s MDR
Browse our complete range of articles by keyword
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