Module 16 2022

02/09/2022

National Laws (France)

Double source

● Undertaking under the conformity assessment procedure

● L 5212-1 and L 5212-2 Code de la Santé Publique

The Organisation for Professionals in Regulatory Affairs

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National Laws (France)

Manufacturer / user / third party ● Who gains knowledge of an incident or risk of an incident implicating the device ● Serious

– death or serious bodily harm – to patient, user or third party ● Notify “sans délai” to ANSM

Special considerations ● Events outside France ● Recalls for “technical or medical reasons” are reportable

The Organisation for Professionals in Regulatory Affairs

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