MDR/IVDR: Confirmation of Extension

On December 9, 2022, the EPSCO Council met. Commissioner Stella Kyriakides emphasized the importance of postponing the applicability of the MDR, proposing the following dates:

  1. Postponement to 2027 for Class IIb and III devices
  2. Extension until 2028 for Class I devices

Furthermore, with this extension request, a derogation of the validity of CE certificates is introduced in accordance with Directive 93/42/EEC.

The Medical Device Coordination Group (MDCG) has published guideline MDGC 2022-18, specifying that manufacturers whose certificate under MDD has expired but have initiated a marking process according to MDR not yet completed can request an exemption from market entry until the issuance of the new certificate.

Thanks to the publication of this Guideline, document PE-CONS 1/23 - 2023/0005(COD) has been drafted, proposing an amendment to Regulations (EU) 2017/745 and (EU) 2017/746 regarding transitional provisions for certain medical devices and in vitro diagnostic medical devices.

On February 16, 2023, the European Parliament approved the Commission's request regarding document PE-CONS 1/23 - 2023/0005(COD).

Therefore, from the moment of publication in the Official Journal of the European Union, the extension of transitional provisions will officially become law, and medical devices and IVDs with a valid CE certificate can immediately benefit from the transition period.

This extension has been granted to medical device manufacturers to allow for better management of the entire certification process to avoid recurring urgent situations.

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