In a recently published guidance document, the MDCG aims to provide guidance to the Member States on handling certain MDR provisions applicable as of May 2021, even though Eudamed is not fully functional. To comply with the current Directives, legal manufacturers and authorised representatives of CE-marked medical devices have to register in the EU country where they have their place of business. The transitional provisions of the MDR state that if Eudamed is not fully functional on the date of application, the corresponding provisions of Directives 90/385/EEC and 93/42/EEC continue to apply. The MDR introduces a much larger Eudamed database than the one that currently exists under the Directives alongside a variety of new registration requirements regarding stakeholders and data exchange and a publicly accessible version to increase transparency. MDCG 2021-1 includes information on how to addresses cases where the exchange of information would be difficult, based on the corresponding provisions of the Directives.
Eudamed is composed of the following six interconnected modules:
- Actors registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
With the MDR fully applying on 26 May 2021, the actor registration module is the only and first of the Eudamed modules currently available. The European Commission launched the Eudamed actor registration module on a voluntary basis on 1 December 2020. This allows competent authorities to assign SRNs (single registration numbers) to each economic operator, which is a precursor to device registration (and plays a role in the documentation of a medical device under MDR). Device registration in Eudamed will not be possible until the UDI/Device Registration module goes live.
When launching the first module, the Commission made clear that it is not in the position to enforce the use of the actor registration module, but asked EU competent authorities to promote the registration process in Eudamed and avoid double registration at a national level. Owing to each country's need to maintain an oversight of the manufacturers on its market, some countries will extend national manufacturer registration to CE-marked products under the MDR and manufacturers, and authorised representatives are subject to double registration if they choose to make use of the available module.
The new MDCG guidance aims to provide a harmonised approach by outlining administrative practices and alternative technical solutions to exchange information until the database is ready. MDCG 2021-1 shows in tabular form how individual specifications in the MDR are to be implemented in the period until Eudamed is available. The document suggests that as soon as a functionality corresponding to a requirement is available in Eudamed, the system may be used even before the notice of full functionality of Eudamed has been published. It also includes relevant information on how to deal with regulatory requirements having no corresponding provision in the Directives, such as:
- Making publicly available of the summary of safety and clinical performance (SSCP):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.
- Data exchange between notified bodies and expert panels during clinical evaluation consultation procedure: Notified bodies should notify the relevant parties by uploading the required information to a dedicated secure directory in CircaBC, using a pre-defined template as soon as it becomes available (organised by the Commission).
- Periodic safety update report (PSUR): For class III devices and for classes IIa, and IIb implantable devices, manufacturers should deliver the PSURs to the relevant notified bodies by appropriate means. Notified bodies should provide the PSURs and corresponding evaluations to the manufacturers and make them available upon request to the competent authority.