Regulatory Authority
Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).
Classification
I, IIa, IIb, III
Quality system
ISO 13485:2016
In the case of a non-European manufacturer it is necessary to appoint a European Authorized Representative.
CE-marked Class I Medical Devices (already marketed in other European Union countries) can be placed on the market immediately, without any communication to the Regulatory Authority.
Manufacturers/European Authorized Representatives (EU REP, in case of non-EU Manufacturers) of Class IIa, IIb and III Medical Devices, must submit a communication to the Regulatory Authority. This notification can only be submitted through the CCPS (Comunicación de Comercialización de Productos Sanitarios) online portal, attaching the documentation relating to the device (CE certificate and labelling: labels and instructions for use).
Applicant
Manufacturer or Authorized Representative.
Timeframe and fees
The communication/notification requires the payment of fees. Once the notification is sent, the (CE marked) device can be immediately placed on the market. The costs and time required for obtaining the CE marking may vary.
Validity
Once the notification is submitted, there is no additional fee required to maintain the device in the CCPS database. The CE mark has a maximum validity of 5 years.
Labelling and documentation language
The documentation required the notification submission must be provided both in the original language (CE certificate, labelling and User Manual), and translated into Spanish (labelling and User Manual only).
Useful information
The website of the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) is constantly updated in Spanish and English.
The CCPS portal is only available in Spanish. Some implantable devices require the implant card.
Like all the Countries of the European Union, Spain will also adopt the New Regulation (EU) 2017/745 on Medical Devices.
It is recalled that such Regulation, approved on April 5, 2017, is then entered into force on May 26, 2017. The full implementation of the New Regulation will take place on May 26, 2021.
