Medical device manufacturers, when putting a medical device into service, are bound by an obligation to make a declaration to the French Agency for the Safety of Health Products (ANSM).

These declarations are made by completing a form which is then sent to the ANSM. This form may be sent by registered mail with proof of delivery or by email with proof of delivery. If it is necessary to make a modification to the initial declaration, a new declaration must be sent to the ANSM following the same process.

As an extra precaution, when sending it by post, make sure to choose a service that offers proof of delivery. If sending via email, on the other hand, the ANSM will promptly send you a confirmation of receipt.

French Public Health Code: Article R 5211-65-1.

If you are a medical device manufacturer, a representative of one of these manufacturers or an individual or legal person and your business is based in France and dedicated to manufacturing, distributing, importing or exporting medical devices, either as your main or complementary activity, you must declare the devices subject to your activity to the ANSM.

French Public Health Code: Article L 5211-3-1

You must also make a declaration if your business activity involves sterilising or assembling medical devices that are going to be placed on the market.

French Public Health Code: Article R 5211-65 + Article R 5211-52 + Article R 5211-67.

This declaration obligation also applies to custom-made medical devices; class I, IIa, IIb and III medical devices; and active implantable medical devices.

Depending on your particular situation, you need to complete parts 1, 2, 3 and/or 4 of the form. 

II. Declaration obligation for medical devices after being placed on the market

1: Which medical devices are subject to this declaration obligation?

French law requires that manufacturers make a declaration when placing class I and custom-made medical devices on the market.

French Public Health Code: Article R 5211-65.

Other types of medical devices will not be subject to this declaration, but instead a notification, which we went into in further detail in this article, will be required.

2: Which professionals are bound by the declaration obligation?

For manufacturers based in France, the European Union or the European Economic Area:

• The manufacturer placing a medical device on the market on its own behalf in the European Union or in the European Economic Area.

• The France-based individual or legal person whose business activity includes sterilising medical devices to be placed on the market or assembling medical devices bearing the CE marking.

For manufacturers not based in France, the European Union or the European Economic Area:

• The manufacturer placing a medical device on the market must appoint a single representative that is either based in the European Union or has an agreement with the European Economic Area. This representative will be responsible for making the declaration to the director general of the ANSM.

French Public Health Code: Article R 5211-65 + Article R 5211-52 + Article R 5211-67.

3: What must be contained in the declaration?

The declaration must include the address of the headquarters of the declarant and the name of the medical device being declared.

The declaration must be accompanied by a copy of the CE declaration of conformity, except in the case of custom-made medical devices, a copy of the CE marking certificate issued by the notified body for class I medical devices and an instruction handbook or sales brochure.

For these class I medical devices, you must specify whether they are sterile, with a measuring function, or both sterile and with a measuring function.

It is also necessary to complete section 5.1 of the ANSM form.

French Public Health Code: Article R 5211-65.

Once you have correctly declared your activity to the French Agency for the Safety of Health Products, you may also want to place medical devices superior to class I on the market, in which case you must also fulfil the notification obligation, as detailed in this article.