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Progress In Aligning EU’s Risk Management Standard With New MDR And IVDR

 
• By Amanda Maxwell

The medtech sector can be hopeful now that the updated medical device risk management standard, EN ISO 14971, will be officially published soon so it can be used to demonstrate compliance with the new EU medical device regulations.

risk calculator concept dial showing low, medium and high risk scale

December 28 is the deadline for the public enquiry on two documents that will link the international medical device risk management standard, EN ISO 14971, with the Medical Device Regulation and IVD Regulation. The MDR applied on 26 May 2021, and the IVDR is due to apply from 26 May 2022.

This horizontal standard is a vital cornerstone of the EU medtech regulatory system, used throughout the sector. Once the update...

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