February 1, 2023
By Annette van Raamsdonk and Evangeline Loh
While it has been said the European legislative process is protracted, this has not been the case with the proposed Amendment to the Regulations (December 2022). As we’ve reported, there was the EC proposal (15520/22) and then the subsequent Amendment (2023/0005 (COD)) which the EC submitted to the Council and European Parliament (EP) (January 6, 2023) to “mitigate the risk of shortages of medical devices on the market.” Our previous regulatory updates discuss the amendment to Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) timelines.
As a reminder, the two most significant aspects are the extensions for legacy devices: for legacy Class III and Class IIb implantable devices have until the end of December 2027 and for all other legacy devices including MDD Class I self-certified, up-classified per the MDR, to the end of December 2028. Of course the conditions of Article 120(3) “no significant change to design and intended purpose” applies. And, the sell-off provisions to both the MDR and IVDR are deleted.
The Permanent Representatives’ Committee has agreed to the text and the Presidency is now to enter into negotiations with the EP (Interinstitutional File 2023/0005(COD)) January 26, 2023). The file reports that it is expected that the EP vote on the text during their plenary February 13-16, 2023 through an urgency procedure. In addition, as the proposal is related to public health, the Committees of the European Economic and Social Committee and the Committee of the Regions must be consulted. The committees have been encouraged to “deliver their opinion as quickly as possible.”
Suffice it to say, the legislative system has been charged with advancing this EC Amendment; and, it appears as the text was initially drafted. It seems the amendment will be adopted by the end of Q1/before April. Emergo by UL will continue to post updates as they become available.