On June 26, 2018 the Spanish Regulatory Authority AEMPS issued a specific Information Note stating that as of July 4, 2018 a new CCPS Portal (Comunicación de Comercialización de Productos Sanitarios) will replace the PMPS Portal (Comercialización y Puesta en Servicio de Productos Sanitarios).
The PMPS Portal will stop managing communications and it will be only used as a database for consultation.
The CCPS Portal aims to:
– Manage registration of marketing communications relating to:
- Class IIa, IIb and III Medical Devices;
- Active implantable Medical Devices;
- Self-diagnostic devices; and
- In vitro diagnostic Medical Devices (Annex II of the Royal Decree 1662/2000).
– Eliminate any possible shortcomings, if necessary, until the communication is noted.
– Allow the modification of already noted marketing communications data.
– Check marketing communications status.
All actions relating to marketing communications (submission, correction of deficiencies and/or changes) must be carried out via the new CCPS Portal.
The CCPS Portal User Manual describes in detail both its functions and the method to recover PMPS existing communications.
For further information:
