Obelis European Authorized Representative Center"CE Marking Consultants with a Reputation for Excellence"
Under the Decree n° 2002-1221 September 30, 2002 and Decree n°2010-270 March 15, 2010, four categories of medical devices require to be registered with the French Agency for the Sanitary Security of Health Product (AFSSAPS) at the time of being put into service within French territory (click here for official letter by AFSSAPS).
Categories of medical devices concerned by this obligatory communication are:
1. Class IIa medical devices
2. Class IIb medical devices
3. Class III medical devices
4. Active implantable medical devices (AIMDD)
The registration process consists of following 5 steps:
1. Designation of an E.A.R.!
2. Provide E.A.R. with relevant documentation (to be provided upon request)
3. E.A.R reviews your documentation
4. E.AR communicates the information to AFSSAPS
5. 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:
1. 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);
2. 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;
3. Third party commercial entity will expect exclusivity, limiting the open distribution of devices.
1. For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs;
2. The manufacturer should register their products with the French Authorities through his appointed Authorized Representative.
Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France and Germany) and strengthen the need for a professional European Authorized Representative present at all times.
Contact us now to find out more.