Ensuring the safety and performance of in vitro diagnostic medical
https://eur-lex.europa.eu/EN/legal-content/summary/ensuring-the-safety-and-performance-of-in-vitro-diagnostic-medical-devices.html
What Is The Aim of The Regulation?Key PointsFrom When Does The Regulation Apply?BackgroundMain DocumentsRelated Documents It updates the rules on placing on the European Union (EU) market, making available and putting into service in vitro diagnostic (IVD) medical devices* for human useand their accessories.It also contains rules on the conduct of performance studies*for IVD medical devices or accessories. It updates the rules on placing on the European Union (EU) market, making available and putting into service in vitro diagnostic (IVD) medical devices* for human useand their accessories.It also contains rules on the conduct of performance studies*for IVD medical devices or accessories.It aims to improve patient safety by introducing stricter procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market)and post-market surveillance.See moreNew content will be added above the current area of focus upon selectionSee more on eur-lex.europa.eu It updates the rules on placing on the European Union (EU) market, making available and putting into service in vitro diagnostic (IVD) medical devices* for human useand their accessories. It also contains rules on the conduct of performance studies*for IVD medical devices or accessories. It updates the rules on placing on the European Union (EU) market, making available and putting into service in vitro diagnostic (IVD) medical devices* for human useand their accessories. It also contains rules on the conduct of performance studies*for IVD medical devices or accessories. It aims to improve patient safety by introducing stricter procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market)and post-market surveillance.
It updates the rules on placing on the European Union (EU) market, making available and putting into service in vitro diagnostic (IVD) medical devices* for human useand their accessories.
It also contains rules on the conduct of performance studies*for IVD medical devices or accessories.
It aims to improve patient safety by introducing stricter procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market)and post-market surveillance.
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