MDR Art. 52
Conformity assessment procedures
Determines, by device class, the applicable procedure and the role of the notified body
- 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
The class drives the procedure. Class I is self-declared, except for sterile devices (Is), devices with a measuring function (Im) and reusable surgical instruments (Ir), where the notified body intervenes on that aspect alone (paragraph 7). Classes IIa, IIb and III go through Annexes IX, X or XI. Classification itself is governed by Article 51 and Annex VIII, not by this article.
Official sources
https://eur-lex.europa.eu/legal-content/FR/TXT/?uri=CELEX:32017R0745See where this text lands in your roadmap
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