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06:56:452026-01-31

Notified Body 0318 and Certification 13485

AEMPS HEADQUARTERS > Procedures > Notified Body 0318 and Certification 13485 > CNCPS
Access to the app
Target persons

The application is aimed at companies or organizations that carry out activities of design, manufacture, production and control of sanitary products, including those that provide related services.

The application is aimed at the electronic registration and management of the requests necessary for the processing and monitoring of:

  • CE marking of medical devices and medical devices for in vitro diagnosis by ON 0318
  • The certification of quality management systems according to the UNE EN ISO 13485 standard by the AEMPS, under ENAC accreditation and IAF MLA mark
Request for access

Entities wishing to perform the procedures referred to in the previous section electronically must request access credentials (username and password) by sending an access request through the following link:

https://servicedesk.aemps.es/servicedesk/customer/portal/2/, option “Access Management – Access Request”, indicating as data of the application “CNCps.

The following data will be provided(1):

  • User Data:
    • Name
    • Surnames
    • NIF. In the case of foreigners, the tax identification code is required
    • Country
    • Email address
  • Data of the entity, or entities, to which it must be associated
    • Name
    • CIF. In the case of foreigners, the VAT (European) or the tax identification code is required
    • Country

Multiple users can be provided by each entity, if applicable, by all people in the organization who must access the application.

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.

1It is reported that your personal data will be incorporated into a computer file that will be safeguarded by the Spanish Agency of Medicines and Health Products. The communication of personal data to third parties is not foreseen. At any time you can exercise your rights of access, rectification, deletion and portability of your data, limitation and opposition to its processing by writing to the AEMPS, c/ Campezo 1, edificio 8, Parque Empresarial Las Mercedes, 28022, Madrid, or at the email addressdelegado_protecciondatos@aemps.esin accordance with the provisions of Regulation (EU) 679/2016 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and Organic Law 3/2018 of 5 December on the Protection of Personal Data and the Guarantee of Digital Rights

Documentation

The application will include on each screen, a link to the user manual.

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.
Notification of errors

APPLICATION

If you experience errors or difficulties with the application, please let us know by registering a request at the following link:https://servicedesk.aemps.es/servicedesk/customer/portal/2/(application “CNCps”)

Include as much information as possible about the incident, including screenshots, error messages, etc. To make it easier for our technicians to detect and resolve the problem.

FEES

For fee-related issues, if you experience errors or difficulties regarding the payment of fees, please let us know by registering a request at the following link:

https://servicedesk.aemps.es/servicedesk/customer/portal/2/(Incidents –Application FEES)

USE

For questions related to the logic or use of the application, contact us at the address:validacionregelectronicoon@aemps.es