The launch of EUDAMED for May 2022, which correlates with the date of application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). In this regard, the official launch of EUDAMED in May 2022 does not affect the date of application of the MDR on 26 May 2021.
MDR addresses the possibility that EUDAMED is not fully functional on the date of application of the MDR (26 May 2021). Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC4 and 93/42/EEC5 shall continue to apply for the purpose of meeting the obligations regarding the exchange of information.
Alternative solutions to submit and/or exchange information (as required under the MDR)
Manufacturers should refer to the national provisions in Member States establishing product registration schemes. Obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2021 and Labelling requirements apply gradually, starting from 26 May 2021.
2. Registration of manufacturers , authorised representative s and importers
Manufacturers, authorised representatives and importers should refer to the national provisions in Member States. Please refer to MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States.
3. Summary of safety and clinical performance
The SSCP shall be made available to the public upon request without undue delay or the manufacturer shall specify where it is made available to the public. As soon as the functionality is available in Eudamed, the system may be used for the upload of the SSCP even before the notice of full functionality of Eudamed has been published.
4. Certificate of Conformity
Certificates will be made available upon request or will be uploaded in the national system where required.
5. Application for clinical investigations
The application for clinical investigations should take place via the respective national procedures applicable to clinical investigations.
6. CircaBC Centre for Administrations, Businesses and Citizens)
The Commission has made available the list to Member States by means of a dedicated secure directory in the Communication and Information Resources Centre for Administrations, Businesses and Citizens (CircaBC). It is used for following purpose…
- Nomination of experts for joint assessment of applications for notification
- Changes to designations and notifications
- Involvement of notified bodies in conformity assessment procedures
- Clinical evaluation consultation procedure for certain class III and class IIb devices
- Mechanism for scrutiny of conformity assessments of certain class III and class IIb devices
- Market surveillance activities