Industry Asks Commission To Delay MDR Full Compliance Dates By At Least Two Years

The two largest EU national medtech industry associations, France’s Snitem and Germany’s BVMed, have joined forces to call on the European Commission and other authorities to act now so the MDR and IVDR don’t result in “disaster for patients”.

Delay

They want the grace period extended by a further two years, from 2024 to 2026 for the highest risk class products (Class III and implantables), and by four years, from 2024 to 2028, for all other devices.

Currently, the grace period gives eligible manufacturers an additional three years beyond the 26 May 2021 date of application to certify under the new MDR.

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