Medical Devices - Sector - Latest updates

Implementing Regulation (EU) 2026/977 – uniform requirements for conformity assessment and notified bodies (Annex VII)

Update - New manufacturer incident report XSD files and XSL files (SB 11154)

Update – Documents on European Medical Device Nomenclature (EMDN)

Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v5

Update - MDCG 2021-24 rev.1 - Guidance on classification of medical devices (April 2026)

Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics

Rev.2 - Q&A Obligation to inform in case of interruption or discontinuation of supply

Article 10a Decision tree

Recording available - Second training on EMDN: structure, consultation process, and practical application

Recording available - Commissioner Várhelyi to open high-level event on medical devices

Commissioner Várhelyi to open high-level event on medical devices

Medical Devices: Register now for high-level conference on 16 March 2026

Registration - High-level Conference on Medical Devices: Innovation and Patient Safety - 16 March 2026, 9.00 - 17.00 CET

MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices (December 2025)

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

Factsheet - Better rules for medical devices, better outcomes for EU patients

New measures to make EU health sector more innovative, competitive and resilient

MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746

Monitoring of availability of medical devices on the EU Market - Study overview and 2nd survey results