Requests For Additional Information During EU Audits – What To Expect And How To Avoid Them
A trend toward additional information demands from EU notified bodies risks delays and additional costs. One regulatory expert comments how the EU expectations are now closer to those in the US.
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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.