BREAKING NEWS
Just released: Commission Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions (Brussels, 3.4.2020 COM(2020) 144 final – 2020/0060 (COD))
Full text in DE, EN and FR: COM(2020) 144 final – 2020/0060(COD)
The Commission adopts the proposal aiming to have the Parliament and Council adopt the proposal by the end of May.
Of special note:
– No changes are introduced for the key date of 27 May 2024 when MDD/AIMDD certificates with an expiry beyond 26 May 2021 become void.
– Common specifications for Annex XVI devices to be adopted by 26 May 2021. They shall apply as from 6 months after the date of their entry into force or from 26 May 2021, whichever is the latest.
– No changes proposed to the current IVDR legislation.
– Eudamed and UDI phase-in dates in article 123 (3) (g) MDR are swifted by 2 years to align aiming to have Eudamed entering into force along with IVDR.
