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Listed below are some of the most recent publications supporting the implementation of the EU IVDR.
December 2025:
- (New) First publication: MDCG 2025–10 - Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices.
- 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 under Regulations (EU) 2017/745 and 2017/746.
July 2025:
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.
- 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).