Just Four Items Remain On European Commission’s High Priority IVDR List
The IVD Regulation has applied in the EU since 26 May this year. This year has seen a rapid output of IVDR guidance and other implementation documents. Soon the list will be completed.
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The Council of EU’s agenda for the critical upcoming health council meeting confirms position of EU Medical Device Regulation in day’s running, along with other key health issues.
Certain active products without an intended purpose, where member states had concerns over potential inadequate regulation, now fall under stricter Medical Device Regulation rules.
Damage limitation action is expected imminently to try and stem the flow of medtech products being taken off the EU market. And it cannot come quickly enough as evidence continues to mount of the negative fall-out resulting from the way the EU’s new medical device regulations have been, and are being, implemented.