EU MDR 2017/745 is now consolidated + New EU Regulation Streamlines Joint Scientific Consultations for Medical Devices

Dear Reader

Please find below the latest news related to medical devices and in vitro diagnostic devices in Europe.

Regulation and Guidelines:

EU MDR 2017/745 - Consolidated version

The European Commission has published a new consolidated version where they have integrated the reference to "Regulation (EU) 2024/568 of the European Parliament and of the Council of 7 February 2024". The consolidated version can be downloaded with the link below.

Link to document

Regulation (EU) 2025/117 - laying down rules for the application of Regulation (EU) 2021/2282 with regard to the procedures for joint scientific consultations on medical devices and in vitro diagnostic medical devices

It outlines the processes for health technology developers to request and participate in joint scientific consultations with the Coordination Group on Health Technology Assessment. The regulation covers the submission of requests, selection and consultation of experts, and cooperation with expert panels when consultations are conducted in parallel.

Link to document

What else could be interesting:

EU C/2025/485:

Urgent need to revise the medical device regulation

Document →

IMDRF/AIML WG/N88:

Good machine learning practice for medical device development: Guiding principles

Document →

IMDRF/SaMD WG/N81:

Characterization Considerations for Medical Device Software and Software-Specific Risk

Document →

New Partner:

We are thrilled to announce a strategic partnership between Asia Actual and Regulatory Globe GmbH. This collaboration unites Asia Actual's expertise in Asian markets with Regulatory Globe's AI-powered solutions for global medical regulations.

Asia Actual specializes in helping manufacturers navigate medical device market entry and expansion in Asian markets. Their services include regulatory strategy, registration, independent license holding, importing and commercial assistance for all types of medical devices.

Elly - Your personal Regulatory Affairs Assistant:

Use-Case: Initial Regulatory Assessment

It does not matter in which language, how large, or how complex the regulation is. Elly will do for you the initial assessment. How it works? See the video below: