Under the MDR, clinical evaluation is "a systematic and planned process" (Article 2(44)), and Annex XIV Part A Section 1(a)
Summary The EU AI Act data requirements place specific expectations on how manufacturers manage the data used to develop, validate
On 21 October 2026, the UK government confirmed that it will continue to accept CE-marked medical devices in Great Britain
In the US, three sets of rules govern a medical device recall: FDA's recall policy in 21 CFR Part 7
The harmonised standards under the MDR are listed in Commission Implementing Decision (EU) 2021/1182 and its amendments. The most recent
The IVDR, Regulation (EU) 2017/746, has applied since 26 May 2022. It replaced the list-based approach of Directive 98/79/EC with
For FDA's fiscal year 2027, which started on 1 October 2026, the standard user fee for an original PMA is
In February 2026, FDA issued "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions". It supersedes
Article 5(2) of the MDR requires a device to meet the general safety and performance requirements (GSPR) in Annex I
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