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The EU-commission on 23.01.2024 published several documents detailing proposals with the aim to improve transition to MDR and IVDR and ensure availability of devices. These encompass a press release, a Q&A page, a Factsheet and a proposal for a new Regulation to change MDR and IVDR.

The EU Commission published an overview of the language requirements for MDR and IVDR in accordance with the respective national law in the member states. The lists are not binding and do contain some empty cells and unconfirmed information but provide a good overview.

The EU published 3 new and updated additional 3 guidance documents in December 2023.

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).

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.

The EU has published a Q&A document dealing with answers to important questions on the changes to the MDR and IVDR transitional arrangements.

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..