FR-MATERIOVIGILANCE
Materiovigilance (France)
Surveillance system for incidents involving medical devices
- Category
- Post-market
- Market
- France
- Applicable classes
- Class I medical device, Class IIa medical device, Class IIb medical device, Class III medical device
In practice
Since the MDR, the manufacturer’s reporting deadlines are those of Article 87: 15 days as a general rule, 10 days in the event of death, 2 days in the event of a serious public health threat. The local materiovigilance correspondent is an obligation of health institutions, not of manufacturers. The ANSM remains the competent authority and national contact point.
Official sources
https://ansm.sante.fr/page/la-surveillance-des-dispositifs-medicauxSee where this text lands in your roadmap
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