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Hello,
Seeking advice on a couple of unclear matters regarding commercialization of an IVD in France. First, the IVD in question is a general, self-declare class I IVD that is CE-marked and registered with the local CA of the member state in which our company is located.
- Do we need to notify ANSM prior to commercializing the device? If so, how?
- Do we need to appoint a Vigilance representative and notify ANSM? If so, does this person need to be in-country? I've seen a Form to this effect, but can't locate a current copy and was hoping someone here might have past experience navigating this issue.
Thank you in advance and Happy New Year to all.