Medical Device Registration in Spain

Under the Spanish Royal Decree No.1591/2009, of the 16th of October and the No.1662/2000, of the 29th of September, four categories of medical devices and three categories of IVDs require to be registered with the Spanish Agency for Medicines and Health Products (AEMPS) at the time of being put into service within French territory.

Categories of medical devices/IVDs concerned by this obligatory communication are:

  • Class IIa medical devices
  • Class IIb medical devices
  • Class III medical devices
  • Active implantable medical devices (AIMDD)
  • IVD Self-Testing
  • IVD Annex II, List A
  • IVD Annex II, List B

Registration Process

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. A.R reviews your documentation
  4. AR communicates the information by using the Official AEMPS Web-Portal
  5. A.R provides you with an acknowledgement of delivery and Certificate

Additional Information

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 least 30 days before putting the medical device into service (article 1 of the MDD 93/42/EEC) onto the Spanish territory.

Please bear in mind, that if the communication is not submitted at the time the device is put into service, the Spanish Laws are laying down penalties for the contraveners.

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.

Conclusion

  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, Greece, Latvia, Bulgaria and Croatia) and strengthen the need for a professional European Authorized Representative present at any time.

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