EU Regulation Transitional Amendments Enter into Force

The much-anticipated amendments which were proposed in December of 2022 and approved earlier this year have now been published in the Official Journal of the EU (OJEU) (no. L80) as Regulation (EU) 2023/607. This means that the amendments have entered into force.

What has been amended?

The key amendments made revolve around an extension to the validity period of MDD and AIMDD certificates and the transition period to the EU MDR.

  1. MDR Article 120(2): Legacy certificate validity extensions and related provisions.
  2. MDR Article 120(3): Amended transitional provision timelines and lays out important conditions to be met as well as other related provisions.
  3. MDR Article 120(4): Removal of “sell-off” clause.
  4. MDR Articles 122 and 123: Amended to reflect the Article 120 changes.
  5. IVDR Article 110(4): Removal of “sell-off” clause.
  6. IVDR Article 112: Amended to reflect the Article 110 changes.

Read our in-depth article, here.