On 16 February 2023, the European Parliament approved the European Commission's proposal for amending the EU's Medical Device regulatory framework.
The extension of the transitional period applies only to medical devices placed on the market before 26 May 2021. The extension of the transitional period lasts until 2026–2028, depending on the risk class.
EUR-Lex has published various language versions of the proposed amending Regulation that describe the new staggered, extended transitional periods for medical devices of different risk classes.
As the European Commission published several new documents around the turn of the year, the Finnish Medicines Agency (Fimea) yesterday (23 February 2023) published on their website a list of New and updated MDCG guidance documents published to support medical device operators.