Medical Device Regulations in France Explained

Regulatory Agency

The National Agency for the Safety of Medicines and Health Products (ANSM) regulates the medical devices in France.

Medical Device Definition

Medical Device: Any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, in humans for one or more of the following specific medical purposes:

Diagnosis, prevention, control, prediction, prognosis, treatment or mitigation of a disease;
Diagnosis, monitoring, treatment, mitigation of an injury or disability or compensation for such injury or disability;
Investigation, replacement or modification of an anatomical structure or function or of a physiological or pathological process or state;
Communication of information by means of in vitro examination of samples from the human body, including organ, blood and tissue donations.

And whose principal intended action in or on the human body is not achieved by pharmacological or immunological means or by metabolism, but whose function can be assisted by such means.

Medical Device Classification System

Classification	Risk Level	Examples
l Ir (reusable) Is (sterile) Im (measuring)	Low Risk	Wheelchairs, Stethoscopes, Spectacles
IIa	Medium Risk	Dental fillings, Surgical clamps, Tracheotomy tubes
IIb	Medium High Risk	Lung ventilators, Bone fixation plate, Condoms
III	High Risk	Pacemakers, Heart valves, Implanted cerebral simulators

Regulatory Approval Process

Classification	Approval Procedure
I	The ANSM encourages manufacturers to register the marketing of their devices directly in EUDAMED, this European registration constitutes registration with the ANSM under national provisions. Since May 26, 2021 including the agents can no longer declare/register the placing on the market of the devices. This responsibility lies with the manufacturers.
I Im Is lr	Confirm the classification based on Annex VIII of MDR, considering its intended use and risk. Manufacturers outside the EU must appoint an Authorised Representative (AR). Devices with a measuring function or sterile/reusable, it becomes Class I(m), I(s), or I(r) and requires Notified Body involvement. While ISO 13485 is not mandatory for Class I, it is strongly recommended. Manufacturers must maintain documentation demonstrating compliance with General Safety and Performance Requirements (GSPR) in Annex I of the MDR. Even Class I devices require a clinical evaluation, which may be based on literature, existing data, or equivalence to a similar device. Draft and sign a Declaration of Conformity (Annex IV of MDR), stating the device complies with all applicable MDR requirements. Once the DoC is in place, the CE marking can be affixed on the product, packaging, and IFU. The company must be registered as an Economic Operator in EUDAMED The device must be registered with basic UDI-DI in EUDAMED
lla llb lll	Classify the device according to the MDR. If a medical device manufacturer is based outside the European Union (EU) or the European Economic Area (EEA), they are required to appoint a European Authorized Representative. Prepare technical documentation for conformity assessment. Submit the documentation to notified body. Notified body will issue CE certificate. Issue Declaration of Conformity and affix the CE mark. Register the device in EUDAMED. The validity of a medical device’s certificate issued by notified body is 5 years.

Classification

Approval Procedure

The ANSM encourages manufacturers to register the marketing of their devices directly in EUDAMED, this European registration constitutes registration with the ANSM under national provisions.
Since May 26, 2021 including the agents can no longer declare/register the placing on the market of the devices.
This responsibility lies with the manufacturers.

Confirm the classification based on Annex VIII of MDR, considering its intended use and risk.
Manufacturers outside the EU must appoint an Authorised Representative (AR).
Devices with a measuring function or sterile/reusable, it becomes Class I(m), I(s), or I(r) and requires Notified Body involvement.
While ISO 13485 is not mandatory for Class I, it is strongly recommended.
Manufacturers must maintain documentation demonstrating compliance with General Safety and Performance Requirements (GSPR) in Annex I of the MDR.
Even Class I devices require a clinical evaluation, which may be based on literature, existing data, or equivalence to a similar device.
Draft and sign a Declaration of Conformity (Annex IV of MDR), stating the device complies with all applicable MDR requirements.
Once the DoC is in place, the CE marking can be affixed on the product, packaging, and IFU.
The company must be registered as an Economic Operator in EUDAMED
The device must be registered with basic UDI-DI in EUDAMED

lla

llb

lll

Classify the device according to the MDR.
If a medical device manufacturer is based outside the European Union (EU) or the European Economic Area (EEA), they are required to appoint a European Authorized Representative.
Prepare technical documentation for conformity assessment.
Submit the documentation to notified body.
Notified body will issue CE certificate.
Issue Declaration of Conformity and affix the CE mark.
Register the device in EUDAMED.
1. The validity of a medical device’s certificate issued by notified body is 5 years.

Additional Information

Approval Timeline	Not specified by the agency
License validity period	5 years
Fees	Notified bodies shall establish lists of their standard fees for the conformity assessment activities

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