EU Regulatory Roundup, September 2020: Uncharacteristically Slow As COVID-19/Brexit Wreak Havoc
European Commission medtech news all but dried up in September. But the UK’s Brexit news and implications for medtech has given EU and UK medtech stakeholders enough to ponder.
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With COVID-19 continuing to wreak havoc in the EU just as throughout the globe, the European Commission is proposing new measures that will impact antigen test availability and use
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.