Medical Devices - Sector - Latest updates

Update - MDCG 2020-16 rev.4 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 (March 2025)

MDCG 2019-6 rev.5 - Questions and answers: Requirements relating to notified bodies (February 2025)

Coordinated assessment for clinical investigations: a call for expression of interest

Advice on SARS-CoV-2 on request from the Medical Device Coordination Group (29 January 2025)

Revised versions and new guidance are available in the EMDN section

Revised versions of the PAR templates and the form to apply for designation as NB as well as their annexes are available in the Notified Bodies section

MDCG 2023-3 rev.2 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - January 2025

MDCG 2022-3 rev.1 - Verification of manufactured class D IVDs by notified bodies (December 2024)

Commission launches a public consultation and a call for evidence for EU Medical Devices evaluation

MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

MDCG 2024-15 - Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED (November 2024)

MDCG 2024-14 - Guidance on the implementation of the Master UDI-DI solution for contact lenses (November 2024)

Gradual roll out of EUDAMED - Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 (November 2024)

MDCG 2023-3 rev.1 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - November 2024

Q&A Obligation to inform in case of interruption or discontinuation of supply

MDCG 2022-5 rev.1 - Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices - October 2024

MDCG 2024-13 - Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices - October 2024

MDCG 2021-25 rev.1 - Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC - October 2024

MDCG 2024-11 - Guidance on qualification of in vitro diagnostic medical devices (October 2024)