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07:32:572025-06-25

Notification of clinical investigations with CE marked medical devices for approved indications with variation from standard clinical practice

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

The application is aimed at companies or health professionals who carry out clinical investigations with CE marked medical devices for approved indications with variation of the usual clinical practice and is aimed at:

Manage the notification of clinical investigations with CE marked medical devices for approved indications with variation of usual clinical practice:

  1. medical devices of classes I, IIa, IIb and III, regulated by Royal Decree 1591/2009 of 16 October.
  2. active implantable medical devices regulated by Royal Decree 1616/2009 of 26 October.

Which includes:

  1. Submit request for annotation of clinical research
  2. Correct deficiencies, if necessary, up to the annotation of clinical research
  3. Modifying data from annotated clinical investigations
  4. Check at all times the status of your notifications of clinical investigations

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

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

Request for access

Entities wishing to make the notifications of the clinical investigations referred to in the previous section must request access credentials (username and password) through the link located on the entry screen in the application. Users who already had access keys for the PMPS application do not need to request new keys, they serve the same ones. If you wish, you can request additional keys for the same company. As many access users as each entity requests will be provided.

The access requests will reach the AEMPS, where, after being validated, the user will be registered and will be provided, via email, the username and password with which you can access 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 for 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:
Division of Information Systems of the Spanish Agency for Medicines and Health Products
Las Mercedes Business Park, Building 8
C/ Campezo 1, 28022-Madrid

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 will be available through the AEMPS website at the addresshttps://neops.aemps.eswhere a User Guide/Manual for Notifiers is also available.

Characteristics of the client equipment

What authentication methods will be needed?

  • Digital certificate
  • Electronic DNI
  • 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 (it is known who modifies and what).
  • Time out of connection.
Notification of errors

Any errors related to functionality should be communicated to the AEMPS via e-mail.soporteneops@aemps.es. You can also send detailed suggestions via the same email.