Registration in France
Some categories of medical devices are mandatory to be registered with the French Agency for the Sanitary Security of Health Product (AFSSAPS), at the time of being put into service within the French territory as per the Decree n° 2002-1221 September 30, 2002 and Decree n°2010-270 March 15, 2010.
Categories of medical devices concerned by this obligatory communication are:
- Class IIa medical devices
- Class IIb medical devices
- Class III medical devices
- Active implantable medical devices (AIMDD)
The registration process consists of following 5 steps:
- Designation of an E.A.R.!
- Provide E.A.R. with relevant documentation (to be provided upon request)
- E.A.R reviews your documentation
- E.AR communicates the information to AFSSAPS
- E.A.R provides you with an acknowledgement of delivery
Medical devices having same intended use (same commercial name, the same EC declaration of conformity and the instruction for use) are subject to only one communication. The communication must be made at the time of the putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the French territory.
Please bear in mind, that if the communication is not submitted at the time the device is put into service, article R.5461-1of the code of public health lays down penalties incurred by the contravener.
Third party commercial entities, like distributors, should not register devices for several reasons, a few of which are:
- By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his product in the European Market (such as in France);
- If decided to end the relationship with a commercial distributor at any point, it will be required to take the device completely off the market until a re-registration is completed for a second (third, fourth, etc.) time;
- Third party commercial entity will expect exclusivity, limiting the open distribution of devices.
- For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
- The manufacturer should register their products with the French Authorities through his appointed Authorised Representative.
Local Legislations, such as this one, are common in Europe (Italy, Portugal, France and Germany) and strengthen the need for a professional European Authorised Representative present at all times.
On 26 May 2021, Medical Device Regulation (EU) 2017/745 will repeal Medical Device Directive 93/42/EEC. Until EUDAMED database allowing registration at EU level is functional, current- Directive registration process will continue. Nevertheless, Member States might continue requesting a separate registration to their national database.
For more information on the mandatory pre-market CPNP notification of your cosmetic products, have a look here!
Food supplements may be subject to the requirements of the national registration as a pre-market authorization. For more information, contact us today!
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