Emily Nytko-Lutz

New EU Medical Device Regulations Arrive

Following four years of negotiations, the new EU Regulation on Medical Devices (MDR) (Regulation (EU) 2017/745) and Regulation on In Vitro Diagnostics (IVDR) (Regulation (EU) 2017/746) came into effect on 26 May 2017.[a] These regulations apply to a broad range of products – from syringes and bandages to hip replacements and...

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