Medical device manufacturers: your notification obligations to the ANSM
As we have already explained in another article, medical device manufacturers are obligated to declare their activities to the French Agency for the Safety of Health Products (ANSM). Likewise, they are also required to declare any medical devices that they have placed on the market in France (class I or custom-made). For medical devices of a higher class, on the other hand, manufacturers are not compelled to make a declaration, they simply have to notify the Agency of the device.
Which medical devices are subject to notification to the ANSM?
This communication is required under French law for all medical devices in classes IIa, IIb and III, as well as all active implantable medical devices. A declaration is mandatory for Class I and custom-made medical devices, however.
French Public Health Code: Article R 5211-66.
Which professionals are bound by the obligation to notify the ANSM?
This obligation to notify the director general of the ANSM is applicable to manufacturers, representatives and distributers of medical devices once they are put into service in France by any of the aforementioned.
French Public Health Code: Article R 5211-66.
What must be contained in the notification to the ANSM?
For class IIa, IIb and III medical devices and active implantable medical devices, the notification to the ANSM must include:
The commercial name of the medical device.
The name and address of the person who is responsible for the notification.
An example of the labelling and the instructions for the medical device in French.
Take extra care if any materials of animal origin are used during the manufacture of the medical device as this, in addition to the species of the animal, must be stated in the notification. This must be included in the “Type and species of animal” column.
You must also complete section 5.2 of this form.
French Public Health Code: Article R 5211-66.
How must this notification be sent to the ANSM?
The notification must be sent to the ANSM either by sending it to the address indicated on the form by registered mail with proof of delivery or by sending an email with proof of delivery to communications.dm@ansm.sante.fr. If you choose the latter option, the ANSM will send you send you an email confirming correct receipt of the notification.
If it is necessary to make a modification to the initial notification, a new notification must be sent to the ANSM following the same process.
French Public Health Code: Article R 5211-65-1.
This declaration model was established by the French Health Ministry order of 4 May 2012, modifying the order from 20 December 2011 on the declaration and notification of medical devices, which was implemented by Article R 5211-65-1 of the French Public Health Code, in its annex.
The form can be easily accessed via ANSM'swebsite.
