At the beginning of October 2021 in the EUDAMED database section of the European Commission website, two new modules have been published: “UDI/devices registration” and “Notified Bodies and certificates”.
The creation of EUDAMED represents one of the most relevant aspects of the MDR (UE) 2017/745 and IVDR (UE) 2017/746 Regulations. This system is not, indeed, only developed to categorise medical devices and IVDs, but also a useful tool to supervise the lifecycle of each device, enhance transparency, and the coordination of information on medical devices and IVDs available on the EU market.
EUDAMED consists of a multipurpose informatic system made up by six different modules needed for specific activities:
- Economic operators’ registration (“Actor registration module”) available from December 1st, 2020. For further information concerning this module, read our article.
- UDI/ Devices registration.
- Notified Bodies and Certificates.
- Clinical Investigations and performance studies.
- Vigilance and post-market surveillance.
- Market Surveillance.
“UDI/ devices registration” and “Notified Bodies and certificates” module
Besides the Actor registration module, EUDAMED second and third module, the “UDI/ devices registration” and the “Notified Bodies and certificates”, are now also available.
In the UDI/ devices Registration module it’s possible to look for UDI-DI, and information about medical devices and IVDs. In order to launch the research, several information is required, such as manufacture’s name, Actor ID/SRN, application field, device type, and devices risk class.
The Notified Bodies (ON) and certificates module allows to look up which ONs have already been recognised and registered on NANDO (Notified Bodies database), what kind of certificates have been issued and if they are still valid.
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It is known that EUDAMED will be fully operative only once the entire system and its various modules will be totally functional. After providing the first three modules, it will be necessary to wait for the publication of the three remaining ones (Clinical Investigations and Performance Studies, Vigilance and post-market surveillance and Market Surveillance).
Despite EUDAMED’s delay, it is recommended to take steps because the procedures and activities to be carried out require a certain amount of time and energy.
For this reason, if you are an Economic Operator (EU and non-EU Manufacturer, Authorised Representative, system manufacturer, and medical devices and in-vitro diagnostic medical devices importer) Thema can support you in all strategic activities needed to comply with MDR (EU) 2017/745 and IVDR (EU) 2017/746 including registering in EUDAMED and notifying to the Ministry of Health of the member State that will issues the SRN code (Single Registration Number) upon the activation of the authorisation.