Europe – IVDR: Commission proposes to delay implementation amid ‘grave’ notified body shortage

Amid concerns of a market collapse and a « grave shortage » of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delayed by one year a month before its original date of application in May 2020 due to COVID-19. (RELATED: European Commission proposes to delay MDR by a year due to COVID-19Regulatory Focus 3 April 2020; MDR delay official as industry calls to push back IVDRRegulatory Focus 24 April 2020)…