Targeted Evaluation of the MDR & IVDR: Summary Report on Open Consultation Responses
23 June 2025
eIFUs Now Allowed for All Professional Use Devices: EU Amending Regulation 2025/1234 Published
26 June 2025Table of Contents
Overview
MDCG 2019-11 Rev. 1 is available: HERE
The guidance underwent a fairly significant rewrite (see examples in images below).
Changes include the following:
- Significant expansion to the notes under Section 3.2 Medical Device Software (MDSW).
- Expansion to Section 7 on Modules.
- Additional context on when Electronic Health Record (HER) Systems may qualify as a medical device. Plus, reference to the new European Health Data Space (EHDS) Regulation.
- New examples added throughout.
Examples of Changes
