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.
EC Medical Devices · EU-wide
Source
EC Medical Devices
EC Medical Devices is an official public source that HealthSignal monitors for Medical Devices & IVD. The most recent updates we have tracked from it are listed below, each normalised into our index and linked back to the original publication on the source's own website.
Regulation
Category
Type · Breadth
Date
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.
EC Medical Devices · EU-wideUpdate - 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.
EC Medical Devices · EU-wideCommission 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.
EC Medical Devices · EU-widePublication 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.
EC Medical Devices · EU-wideMDCG 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.
EC Medical Devices · EU-wideSectorial 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 · EU-wideMDCG 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.
EC Medical Devices · EU-wideEC Medical Devices: Publications
EC Medical Devices · EU-wide
Showing 9 of 9 tracked updates
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