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Listed below are some of the most recent publications supporting the implementation of the EU MDR.
May 2026:
- Update: new manufacturer incident report PDF file (SB 11154) and important information about which MIR 7.3.1. versions are accepted from 1st May 2026.
April 2026:
- (New) First publication: Article 10a Decision tree - points to consider in the assessment of an interruption or discontinuation of supply of a device falling under Article 10a (Regulation EU 2024/1860).
- Update: Rev.2 - Q&A Obligation to inform in case of interruption or discontinuation of supply.
- Update: MDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 2026).
- Update: Documents on European Medical Device Nomenclature (EMDN).
- Update: Manual on borderline and classification v5 under Regulations (EU) 2017/745 and 2017/746.
- Update: New manufacturer incident report XSD files and XSL files (SB 11154).
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.