Question ID: 3203
Regulation Reference: Other
Topic: Other
Status: Rejected
Date of submission: 10 Dec 2024
Question
I have a query regarding the risk classification of medical device software. Is the risk classification for medical device software the same as for other medical devices, or are they considered separate? Your clarification on this matter would be greatly appreciated.
Background of the question
related to MDR
EIOPA answer
This question has been rejected because the Medical Device Regulation is not within the remits of EIOPA's activity.