New MDCG Guidance documents released

The EU Medical Device Coordination Group (MDCG) has released several new guidance documents in recent weeks, including:

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

MDCG 2025-8: Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles

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

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

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

In addition, the Commission has announced it will host a high-level conference in Brussels on 16 March 2026 entitled “Medical Devices: Innovation and patient safety”, under the auspices of the Cypriot Presidency of the Council.

The conference will feature a keynote address from Oliver Várhelyi, EU Commissioner for Health and Animal Welfare. Participants include representatives from EU regulatory authorities, the Council, the European Parliament, and other experts from EU stakeholders’ associations.

The conference will take stock of the latest developments in the sector and will offer a glimpse into the future following the adoption of the Commission’s proposal for the revision of the medical devices and in-vitro diagnostic medical devices on 16 December 2025.

The draft agenda for the meeting is available online, together with the registration form.