Vigilance And Postmarket Surveillance: Companies Must Avoid Getting Caught Out By May 2021 Deadline
There is no choice: manufacturers must start EU MDR compliance now, however incomplete implementation is. And some MDR clauses apply to all products as of May 2021, regardless of the grace period.
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How TÜV SÜD Issues First Certificate Under EU’s IVD Regulation And Says Technical Documentation Is Key
Notified body TÜV SÜD has issued the first certificate under the EU’s IVD Regulation. The notified body has fundamental advice for manufacturers wanting to ensure their IVDs are compliant in time.
Just as the MDR and IVDR are being implemented, increasing regulatory divergence in Europe is a growing danger to patient safety throughout the EU, not least through increasing costs and impacting device availability.