The Agencia Española de medicamentos y productos sanitarios (AEMPS) has released guidance informing of changes to the communications and commissioning of medical devices carried out using the (Comunicación de Comercialización de Productos Sanitarios) CCPS portal.
AEMPS will use new procedures for reviewing communications and commissioning for medical devices. From now on, it will carry out the evaluation of the conformity and performance characteristics of the products, including the study of the technical documentation based on market control campaigns.
The commercialisation of class IIa, IIb and III medical devices and of active implantable medical devices is subject to the completion and updating of commercialisation communication through the CCPS portal. From today, once a placing on the market communication has been made, alongside the required documentation, a proof of communication will be generated.
Both the new proof of communication model and the updated summary will be available to download. These two documents will be sufficient to justify that the procedures required for the commercialisation of a medical device in Spain have been carried out.
Read the AEMPS article (in Spanish) for further information.