Latest news

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.

EU commission proposal for MDR transitional provisions

On 2023-06-01 the EU commission published its announced proposal for adapted MDR transitional provisions that will now proceed the legislative pathway. The proposal includes extended transition periods until 2027/2028, depending on a device's risk class and additional conditions. Moreover it removes the "sell-off" date for devices already placed on the market (also for IVDs). A press release can be found here.

EU: New guidances - among others for PSURs

The MDCG published several new and updated guidance documents, among these a PSUR guidance document.

MDCG 2022-19 and -20 detail the procedure for application for and changes to performance studies for IVDs. The updated MDCG 2022-4 covers the surveillance for legacy devices and MDCG 2022-21 contains information for the creation of PSURs.

EU: Proposal for prolongation of MDR legacy device transition

AT the EU Employment, Social Policy, Health and Consumer Affairs Council meeting on 2022-12-09 a proposal was agreed upon, to prolong the transition periods for MDR legacy devices. Proposed are staggered timelines until 2027 for class IIb/III devices and until 2028 for all other devices. Further details will be established and introduced to the legislative procedure at the beginning of 2023.

The MDCG has published two new guidelines in the form of MDCG 2021-27 and MDCG 2021-28.

EU – implementing regulation for EUDAMED database published

The EU Commission has published an implementing regulation relating to the EUDAMED database. This governs general questions, e.g. relating to access and registration.

The MDCG has published two additional guidelines in the form of MDCG 2021-25 and MDCG 2021-26, which address the implementation of the MDR for "legacy devices", specifically questions relating to outer packaging/labelling in accordance with Article 16 of the MDR.

The EU Commission has published a proposal for the step-by-step implementation of the in-vitro diagnostics directive, which enables manufacturers to place products in line with the previous directive on the market for longer. Find the press release here.