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
- Free intended use generator – an important tool under the MDR and IVDR
- New European Commission guidance document on MDR medical device classification
- EUDAMED UDI/Devices and NBs/Certificates modules now live
- MDCG 2019-6, rev. 3 lays out provisions for notified body pre-certification services
- bsi article on clinical evaluation requirements under the MDR
- The European Commission publishes important guidance on the requirements for COVID-19 tests under the IVDD
- Team-NB publishes position paper on the applicability of MDR implant card requirements
- 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
Browse our complete range of articles by keyword
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