IDEAL as a guide to designing clinical device studies consistent with the new European Medical Device Regulation

Journal article

### Key messages The evidence demanded by European medical device regulators is getting tougher, especially for high-risk devices. The new European (EU) Medical Device Regulation[1][1] (MDR) has changed the evidence requirements for CE certification. The regulation states, in general terms, what.

Authors: Fleetcroft, C; McCulloch, P; Campbell, B

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BMJ
• Journal: BMJ Surgery Interventions & Health Technologies
• Volume: 3
• Issue: 1
• Pages: e000066-e000066
• Publication date: 2021-03-04
• Acceptance date: 2021-02-01
• DOI: 10.1136/bmjsit-2020-000066
• ISSN: 2631-4940
• Language: English
• Keywords: Key (lock); Ideal (ethics); Certification; International trade; European commission; Medical device; General Data Protection Regulation; Computer security; European union; Business; Risk analysis (engineering); Medicine; Accounting; Computer science; Biomedical engineering; Law; Political science