Medical Device Directives Farewell Party Highlights Advances, Critics And Challenges
Today marks the beginning of a new era. The MDR fully applies and companies can no longer be audited against the Medical Device and IVD Directives to claim compliance with EU regulations.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty guidance documents have been posted on the tracker since its last update.
The new EU regulation on increasing powers of the European Medicines Agency in future health crises applies as of 1 March; it controversially sees the agency become more involved in device oversight.
At last, common specifications for different groups of products that do not have an intended medical purpose but are covered in the scope of the EU’s Medical Device Regulation, are on the way.