This translation has been done automatically by means of the Automatic Translation Platform of the General Secretariat of Digital Administration (PLaTa) and may contain errors or inaccuracies in the interpretation of the content.

02:36:412025-09-29

Computer Application of Medical Devices: Communication of Marketing of Medical Devices (CCPS)

AEMPS HEADQUARTERS > Procedures > Medical Products, Cosmetics, Personal Care and Biocides > CCPS
Access to the app
Target persons

The external module is aimed at the Healthcare Products Industry and is aimed at:

  • Manage the registration of marketing communications from:
    • class IIa, IIb and III medical devices, regulated by Royal Decree 1591/2009 of 16 October.
    • active implantable medical devices regulated by Royal Decree 1616/2009 of 26 October.
    • self-diagnostic medical devices and in vitro diagnostic devices listed in Annex II to Royal Decree 1662/2000 of 29 September.
  • Correct deficiencies, if necessary, until the annotation of the communication.
  • Modify data from annotated marketing communications.
  • Discontinue marketing communications from the database.
  • Check at all times the status of your marketing communications.

All actions related to marketing communications (presentation, correction of deficiencies and/or modification) are carried out through the application.

Users shall be the persons designated by the entities to act on their behalf.

Request for access

Entities that wish to make the communications referred to in the previous section must request access credentials (user and password) through the link located on the entry screen in the application.

In application of article 5 of Organic Law 15/1999 on the Protection of Personal Data, you are informed that your personal data will be incorporated and treated in the automated file CCPS maintained under the responsibility of the Department of Health Products of the Spanish Agency of Medicines and Health Products. The purpose of the file is the management of marketing communications.

In any case, you may exercise your rights of access, cancellation, rectification and opposition in the terms described in the L.O.P.D. 15/1999 of December 13, Protection of Personal Data, by written notification addressed to the Information Systems Division of the Spanish Agency for Medicines and Health Products, Parque Empresarial LAS MERCEDES, Edificio 8, C/ Campezo 1, 28022-Madrid

Users who already have access keys for the PMPS application do not need to request new keys, they serve them. If you wish, you can request additional keys for the same company. As many access users as each entity requests will be provided.

The entity shall be responsible for the custody and management of the use of these credentials within its organization. To prevent fraudulent use by people who have lost the ability to access the application, the password must be changed each time these circumstances occur.

In any case, it is recommended to change the password frequently, and always the first time the application is accessed.

The system will communicate the access keys automatically to the email address provided by the users.

Documentation

The application includes the following user manuals:

Characteristics of the client teams

What authentication methods will be needed?

  • Digital certificate
  • Electronic ID
  • Cl@ve PIN
  • In some cases it will not be necessary to have any method of authentication

What characteristics do the client teams have to have?

  • Next generation browser: Edge, Chrome, Firefox, Safari or similar.
  • The use of Internet Explorer is not recommended.
  • Any PDF document viewer. You can download the Adobe Acrobat Reader at the address http://www.adobe.com/.
  • User authorization and password of RPS.
  • Application security: activate the Java Script option in the browser if it is not active (this option comes by default).

Since it is a Web application, there are no operating system or memory or disk requirements beyond those necessary for the operating system, browser and PDF viewer chosen.

What are the security elements that the applications incorporate?

  • 128-bit SSL communications encryption.
  • User authentication using USER and password.
  • Autenticación de usuario de segundo nivel, mediante TOKEN UNICO por solicitud que el usuario debe introducir para el envío de las mismas.
  • Each external user can only access the data of the entity it represents.
  • Log of accesses and audit of modifications (you know who modifies and what).
  • Time out of connection.
Answers to frequently asked questions (FAQs)

Click hereTo access our list of frequently asked questions related to the application.

For any questions that may arise, please address your query, to the email addresssoporteccps@aemps.es.

Regarding the security elements that the AEMPS CCPS application incorporates are:

  • 128-bit SSL communications encryption.
  • User authentication using USER and password.
  • Autenticación de usuario de segundo nivel, mediante TOKEN UNICO por solicitud que el usuario debe introducir para el envío de las mismas.
  • Each external user can only access the data of the entity it represents.
  • Log of accesses and audit of modifications (you know who modifies and what).
  • Time out of connection.
Notification of errors

Data

If you experience errors or difficulties with the application, please contact us at the address below.soporteccps@aemps.es. Include all possible incident information, including screenshots, error messages, etc. To make it easier for our technicians to detect and resolve the problem.

In any case, it is recommended to consult prior to our FAQs section in case the doubt or solution to the problem was already described there.

Functionality

Follow the same instructions described in the previous section.