General information for EU member state countries that require additional regulatory processes.

As a member state of the European Union, medical devices and IVD devices are regulated according to the relevant EU directives:

The Medical Device Directive 93/42 EEC
The In Vitro Device Directive 98/79/EC
The Active Implantable Medical Device Directive 90/385/EEC.
 
However, in this country, devices that have been CE marked under any one of these directives ARE required to go through additional registration or regulatory processes in order to receive market clearance.

Spanish Royal Decrees 1591/2009 and 1616/2009 require that the Competent Authority be informed before certain medical devices are placed on the market and/or put into service for the first time. This communication consists of a registration in an ad-hoc database, and it concerns the following medical devices:

All class IIa, IIb and class III medical devices
All active implantable medical devices
All self testing and Annex II IVD devices

We can assist you to comply with these additional requirements.  Please fill in the following form and submit your inquiry or discuss it with one of our online specialists.

Let's get your products registered in Spain!

(*) Spanish Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.