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08:23:162025-06-25

Communication of initiation of the activity of manufacturing of medical devices in hospitals for their exclusive use in the centre itself (In house)

HEADQUARTERS AEMPS > Procedures > Health Products, Cosmetics, Personal Care and Biocides > Communication of initiation of the activity of manufacturing of medical devices in hospitals for their exclusive use in the center itself (in house)
Access to the app
Target persons

To all hospitals carrying out the manufacture of medical devices for use exclusively in the centre itself, in order to meet the specific needs of the group of patients to whom the devices are intended, which cannot be met or cannot be met at the appropriate level of operation, by means of another product with equivalent CE marking marketed. This manufacturing is commonly known as manufacturing In house of medical devices.

It does not apply to health centres that manufacture custom-made medical devices.

Request for access
  • The access is made through the electronic headquarters of the AEMPS with a username and password that will be provided by the AEMPS upon request by the interested parties.
  • The coordinator of the hospital must request access to the application for the first time by selecting the option “register as a new centre” and fill in the fields requested.
  • The 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.
Documentation
Characteristics of the client equipment

What authentication methods will be needed?

  • User authentication using USER and password.

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 addresshttp://www.adobe.com/.
  • 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.
  • Log of accesses and audit of modifications (it is known who modifies and what).
  • Time out of connection.
Answers to frequently asked questions (FAQs)

Application security: activate the Java Script option in the browser if it is not active (this option comes by default).

PDF viewer: Adobe Acrobat Reader is recommended. It is possible to download it in the address.

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

Notification of errors

Data

Any error both related to the functionality and the data collected in the application must be communicated to the AEMPS through email.inhouse@aemps.es.

Functionality

Follow the same instructions described in the previous section.