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The EU published 3 new and updated additional 3 guidance documents in December 2023.
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EU - new EUDAMED versions published
The EU has made available a new version of EUDAMED in the productive (v2.11) as well as the playground (v3.4) version. For both databases an “Information Centre” is available (productive version, playground version) that contains general information and documentation (e.g, user guides).
UK - Extension of deadline for placing CE-marked devices on the Great Britain market
In an amendment to the “Medical Devices Regulations 2002”, the timelines for placing CE-marked medical devices and IVDs on the Great Britain market are extended - depending on the class and conformity assessment procedure up until June 30th, 2030. The MHRA has prepared a respective infographic.
The MHRA has published a guidance document detailing their position concerning the adapted MDR transition periods resulting from Regulation (EU) 2023/607.
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EU - Q&A document on changed transitional period published
The EU has published a Q&A document dealing with answers to important questions on the changes to the MDR and IVDR transitional arrangements.
EU - change of transitional provisions published
Regulation (EU) 2023/607 changing the transition timelines for MDR and abolishing sell-off dates for MDR and IVDR was published today in the official journal of the EU. Consolidated versions are not yet available for the MDR and IVDR.
The regulation enters into force with its publication and becomes immediately applicable. MDD and AIMDD certificates that were still valid on March 20, 2023, are automatically extended. For certificates that expired before that date additional conditions must be met..
EU-parliament adopts proposal to change transitional provisions for MDR and IVDR
The EU-parliamant today accepted the commission's proposal for changes to the transitional provisions, especially to Article 120 MDR and Article 110 IVDR, respectively. Consequently these changes have made a significant step towards their entry into force with the publication in the Official Journal of the European Union. The text voted on in its different language version is accessible here.
EU - new and updated MDCG guidance documents
The MDCG published three new and one updated guidance document in January and February 2023:
MDCG 2023-1 deals with in-house devices under MDR and IVDR,
MDCG 2023-2 details rules for the publication of standard fees by notified bodies,
MDCG 2023-3 is a Q&A document on vigilance under MDR and
in MDCG 2020-16 revision 2 small changes were made with respect to the interpretation of classification rules for IVDs, especially companion diagnostics.