Choose your role
Manufacturer
Authorised Representative
Importer
Distributor
Listed below are some of the most recent publications supporting the implementation of the EU MDR.
December 2025:
- (New) First publication: MDCG 2025–10 - Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices.
- Update: MDCG 2025-7 - Rev. 1 - Timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
- Press release: New measures proposed to make EU health sector more innovative, competitive and resilient.
- EU Commission: Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices.
- EU Commission: Questions and answers on simpler and more effective rules for medical devices.
- (New) First publication: MDCG 2025-9 - Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746.
November 2025:
- Announcement: EUDAMED four first modules will be mandatory from 28 May 2026.
September 2025:
- Update - Manual on borderline and classification v4 under Regulations (EU) 2017/745 and 2017/746.
August 2025:
- Update - MDCG 2024-14 - rev.1 - Guidance on the implementation of the Master UDI-DI solution for contact lenses.
July 2025:
- News announcement: Adoption of Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application.
- (New) First publication: MDCG 2025-7 - Position Paper: Timelines of implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles.
- News announcement: Adoption of Decision (EU) 2025/1324 on expert panels in the field of medical device.
June 2025:
- (New) First publication of MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) (June 2025).
- (New) First publication of MDCG 2025-5 - Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746.
- (New) First publication of MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms.
- Update of MDCG 2019-11 rev.1 - Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
- Further update of the new Manufacturers Incident Report (MIR) form PDF 7.3.1 (mandatory from November 2025).