Hot Topics On The EU’s Immediate Regulatory Agenda: Six Documents To Endorse
Vital MDR and IVDR implementation documents and measures are listed for endorsement at the forthcoming meeting of the European Commission’s Medical Device Coordination Group.
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The latest designation of a notified body in the context of the MDR means that the EU only needs one more to make the landmark total of 30. It seems that this may be realized soon.
Companies have been warned if they delay in applying for certification under the new Medical Device and IVD Regulations their products may not be reviewed in time. And the scale of the potential bottleneck is alarming.
Medtech companies will soon be able to reference an updated European version of the international risk management standard when proving compliance with the EU Medical Device Regulation.