The European Medical Device Regulation (MDR) replaced the MDD and the AIMDD and entered into force on 25 May 2017 with 26 May 2021 as date of application. On 27 May 2022 MDD/AIMDD Annex IV certificates become void. By 26 May 2024 all manufacturers must comply with MDR requirements. On that date, all MDD and AIMDD certificates will be void. On 26 May 2025 MDD/AIMDD certified devices can no longer be made available on the market/put into service.

Key changes of the MDR

The major areas of change in the MDR include:

  1.Technical Documentation

  2.Requirements for clinical evaluation and post-market clinical follow-up

    Increased traceability of devices (UDI)

  3.As manufacturer of medical devices, you must ensure that you meet the               relevant regulatory requirements before placing your