MDR Art. 61
Clinical evaluation and clinical investigations
Obligation to carry out a clinical evaluation based on sufficient clinical data, for every device
- Category
- Founding texts
- Market
- European Union
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
- Applicable since
- May 26, 2021
In practice
Clinical evaluation is mandatory whatever the class. The reference guidance under the MDR is MDCG 2020-1, 2020-5, 2020-6 and 2020-13; MEDDEV 2.7/1 rev.4 belongs to the directive era and is no longer the reference. For implantable and class III devices, a clinical investigation is the rule unless one of the exemptions in paragraphs 4 to 6 applies.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0745#d1e8177-1-1See where this text lands in your roadmap
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