European Commission Churns Out EU MDR Documents, Including On ‘Significant Changes’
The European Commission has reiterated that the MDR deadline of 26 May will go ahead despite the COVID-19 crisis, further hampering notified body resources and audit freedoms. It has put its foot on the accelerator by issuing seven new documents.
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For the first time, the EU medtech industry has called on the European institutions to postpone implementation of the Medical Device Regulation and the IVD Regulation until the COVID-19 crisis is over.
The European Commission group responsible for overseeing the implementation of the EU Medical Device Regulation has told the medtech industry to redouble its compliance efforts and ignored industry’s warnings about the current difficulties it is experiencing.
While the UK is moving forward quickly to provide COVID-19 antibody self-testing, the Belgian government considers the tests not sufficiently accurate to be used in the pandemic.