Introduction
The creation of a European database on medical devices (EUDAMED) is one of the key aspects of the new rules on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746) to allow greater transparency and traceability of devices in the European Union (EU).
The European database on medical devices (EUDAMED) is a live directory of economic operators, medical devices, and other related information which intends to provide access to the general public, healthcare professionals and improve coordination between the different Member States in the EU.
Eudamed will be made up of 6 separate modules:
- Actors registration.
- UDI/Devices registration.
- Notified Bodies and Certificates.
- Clinical Investigations and performance studies.
- Vigilance and post-market surveillance.
- Market Surveillance.
Actor Registration
The Actor registration module was the first module available on EUDAMED and was introduced in December 2020. The module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain an actor identifier/single registration number (Actor ID/SRN). The Actors that can be registered on EUDAMED are the following:
- Authorised Representative.
- Importer.
- Manufacturer.
- System/Procedure Pack Producer.
Following a successful Actor Registration, a unique Single Registration Number (SRN) will be issued to the Actor who will now have additional access on Eudamed. This SRN may then show up on various documentation such as Certificates, Declaration of Conformity, PMCF Plans etc.
Although not yet mandatory, we do urge manufactures to register on the actor registration module and obtain their SRN to avoid any delays due to the influx of registrations when EUDAMED becomes mandatory.
Click here for more information and see how we can help you obtain your SRN.
Additional Guidance on Actor Registration
UDI-DI/Device Registration
This module allows manufacturers to register their devices which are placed on the EU market. The manufacturer will be required to register the Basic UDI-DI and subsequently the UDI-DI for all products which are intended to be placed on the EU market. This module is now live and manufacturers have the opportunity to register their devices on EUDAMED on a voluntary basis. That being said, we do urge manufacturers to register their devices before it is made mandatory to avoid any delays.
The intention of this module is to have a live picture of which devices are currently placed on the market and to have full traceability and visibility of UDI-DI. This registration process can be quite tedious, especially with uploading numerous UDI-DI. We recommend that manufacturers should include a documented process within their Quality Management System (QMS) in order to handle these registrations.
It should be noted that even manufacturers of legacy devices will be required to register their products within this module.
Click here for more information and see how we can help you register your device on EUDAMED.
Additional Guidance on UDI/Devices Registration
Notified Bodies and Certificates
Notified Bodies are required to register any information regarding certificates issued and Summaries of Safety and Clinical Performance (SSCP) on this EUDAMED module.
Additional Guidance on Notified Bodies and Certificates
When will this become mandatory?
EUDAMED is not yet fully functional and thus all obligations and requirements related to EUDAMED are currently voluntary; they will become mandatory 6 months after the date of publication of the notice that EUDAMED is fully functional within the Official Journal of the European Union (OJEU). However, we do recommend that actors at least register on the Actor Registrations module and begin to look into the workings of UDI/Device Registration to avoid any delays when EUDAMED registration becomes mandatory.
How we can help
For more information on how we can help please visit our EUDAMED page.
