EC Medical Devices

Medical Devices: Delegated acts on well-established technologies published

Delegated acts establishing criteria and procedures for well-established technologies under the MDR have been published.

MDCG 2025-6 – FAQ on Interplay between the Medical Devices Regulation, In vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act

FAQ clarifying how MDR, IVDR and the AI Act interact in the regulation of AI-enabled medical devices and diagnostics.

Commission Delegated Regulation (EU) 2025/788 amending Delegated Regulation (EU) 2023/2197 as regards the date of application

Commission Delegated Regulation (EU) 2025/788 amends Delegated Regulation (EU) 2023/2197 regarding the application date.

Update - Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - September 2025

European Commission updates the manual on borderline and classification decisions for medical devices and in-vitro diagnostics.

MDCG 2024-14 rev.1 – Guidance on the implementation of the Master UDI-DI solution for contact lenses

Revised guidance on implementing the Master UDI-DI solution for contact lenses under MDR requirements.

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

MDCG position paper on implementation timelines for Master UDI-DI requirements for optical devices.

Publication of dashboard version 3.5 for the Study supporting the monitoring of availability of medical devices on the EU market

European Commission releases version 3.5 of a monitoring dashboard tracking medical device availability and notified body data across the EU market.

Sectorial challenges

Medical devices and In Vitro Diagnostic medical devices (IVDs) have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, tre...

EC Medical Devices: Publications