Last August 2020 the Medical Device Coordination Group (MDCG) published the document MDCG 2020-15 “MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States”, confirming that from 1 December 2020 it will be able the EUDAMED registration module for the Economic Operators.
In addition, last month, the European Commission published an update on the guidelines MDCG scheduled for 2021.
The EUDAMED registration module for the Economic Operators of Medical Devices and in vitro diagnostic Medical Devices
The European EUDAMED database is a multipurpose system that gravitates around 6 interconnected modules:
- Registration of Economic Operators (“Actor registration module”).
- UDI/Devices registration.
- Notified Bodies and Certificates.
- Clinical investigations and performance studies.
- Vigilance and Post-Market Surveillance (PMS).
- Market Surveillance.
With reference to the 1° module (“Actor registration module”), from 1 December 2020 EU and non-EU Manufacturers, Authorised Representatives, system/procedure pack Producers and Importers of Medical Devices and in vitro diagnostic Medical Devices will be able to register with EUDAMED and provide the information necessary to obtain a Single Registration Number (SRN) even before the date of application of the MDR (EU) 2017/745 and IVDR (EU) 2017/746, when the registration will be mandatory.
Receiving the SRN in advance is an advantage, as is can already be included in the relevant regulatory documentation.
The web page “Actor registration module” has already been published in the section dedicated to EUDAMED on the website of the European Commission and it will be active from 1 December 2020.
While as regards the next five modules the Commission has decided that it will make them available on its website gradually as soon as they are functional.
UPDATE 10/03/2021
The second module on UDI/Devices registration and the third module on Notified Bodies and Certificates will become available by September 2021.
MDCG guidelines for 2021
For the 2021 it is in program the publication of various MDCG guidelines. Last month, in fact, the European Commission published the update “Ongoing guidance development within MDCG Subgroups” which shows that some guidance documents have been postponed and they have been added new different guidelines related to the standardization process, Vigilance and Post-Market Surveillance (PMSV), Notified Bodies and IVD. It is possible to find a summary of the documents at the section Guidance – MDCG endorsed documents – MDCG work in progress – Ongoing guidance documents.
Are you an Economic Operator?
Trust Thema! Thema experts are available to proceed on your behalf or support you in the EUDAMED registration up until the notification to the Ministry of Health of the Member State where the economic operator submitting the application is based. The Ministry will then issue the SRN (Single Registration Number) upon the activation of the authorisation.
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