New QMSR Gap-Assessment Tool / New MDCG 2025-7 document

Dear Reader

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

New Tool - QSR to QMSR Gap-Assessment Tool:

We are happy to announce the release of our new tool designed to help you seamlessly align with the new Quality Management System Regulation (QMSR) and ISO 13485:2016.

This is the first generation of our online-based gap assessment tool. Its web-based nature allows us to keep it continuously up to date and paves the way for future enhancements and integrations that will transform how regulatory requirements are managed.

Test Tool

What you can expect:

Identify gaps early
Save time and reduce compliance risks
Clear mapping between QSR, QMSR, and ISO 13485
Helpful insights into similarities, differences and key requirements across QSR, ISO 13485 and QMSR

The tool is currently available at a special 20% discount until August 31. (Prices will increase in September.)

👉 Here you can also find a video about the tool and how it works.

Regulation and Guidelines:

MDCG 2025-7: Timelines of the implementation of 'Master UDI-DI' to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles

This MDCG Position Paper aims to clarify the timelines for implementing the Master UDI-DI for highly individualized devices, specifically contact lenses, spectacle frames, spectacle lenses, and ready-to-wear reading spectacles. It outlines the obligations for labeling the Master UDI-DI and using the UDI/Device registration module of Eudamed, as well as the interrelation between these requirements.

Link to document

COMMISSION IMPLEMENTING DECISION (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devices

This Implementing Decision amends Implementing Decision (EU) 2019/1396 to address certain administrative aspects related to expert panels in the field of medical devices. It also designates an additional expert panel for medical devices and in vitro diagnostics intended for small patient populations, such as patients with rare diseases or children.

Link to document