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Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators

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.

Manufacturers of medical devices should know the Regulations that govern their products, namely the EU Medical Devices Regulation (MDR) and the EU In Vitro Diagnostic Medical Devices Regulation (IVDR).

Various expert working groups have developed MDCG guidance documents to support the interpretation of the Regulations. While some MDCG guidance documents clarify a relatively specific topic, such as the content of a periodic safety update report, others describe the principles of interpreting transitional provisions in general.

Click this LINK to know more about the various guidelines that support MD operators.


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