EIOPA · 3203

Other

Regulation
Other
Topic
Other
Submitted
2024-12-10
Answered
2024-12-18

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

related to MDR

Answer

This question has been rejected because the Medical Device Regulation is not within the remits of EIOPA's activity.

This Q&A is published by European Insurance and Occupational Pensions Authority and is non-binding. It does not constitute legal advice. Updated weekly from official ESA sources.

Similar Q&As

More Q&As on this topic

📋 Track EU financial regulation continuously

Forseti monitors EU financial regulation and delivers personalised alerts anchored to verified official sources.

14-day free trial. No credit card required.