Life Sciences & Healthcare Newsletter - January to February 2023

Proposal for significant change of the medical devices regime - European Commission

Following concerns that have arisen in the European medical device (MD) market regarding the capacity of Notified Bodies and the fact that there is a significant number of medical devices still in transition from Directive to Regulations, the European Commission ("EC") published a proposal for legislative amendment on 6 January 2023, (2023/0005 ( Brussels, 6.1.2023 COM(2023) 10 final, 2023/0005 (COD) - (the "Proposal").
The proposed amendments, while not introducing substantive changes, aim to address concerns regarding Notified Body capacity and consequently the significant number of medical devices still in transition from the old directives to the MDR. This is a situation that threatens the availability of such medical devices on the European market.
Therefore, the Commission's request to extend the period for companies to obtain MDR compliance certificates and the time needed for Notified Bodies to solve pending conformity assessments - and to provide more time for Notified Bodies to eliminate delays in their conformity assessments - seems logical.