EUDAMED
The European Commission clarified that EUDAMED will be completely functional only when all the six modules are available and after confirmation of the functional specifications by an independent audit.
EUDAMED was originally scheduled to be launched in 2020, but it suffered several delays. It is expected a notice of the fully operationalization of the EUDAMED to be published in the Official Journal of the European Union in the second quarter of 2024.
How to submit and/or exchange information (under the IVDR) until EUDAMED is fully functional?
Registration of devices
Before placing a device on the market, the manufacturer shall assign a Basic UDI-DI to the device and shall provide it to the UDI database, together with the other data elements.
Until EUDAMED is fully functional:
- The system can be used on voluntary basis for registration of devices.
- The manufacturers must consider national provisions related to product registration.
- The obligation of UDI assignment (Basic UDI and UDI-DI) applies since 26 May 2022.
- The labelling requirements will apply gradually, starting from 26 May 2023.
Registration of manufacturers, authorised representatives and importers
Before placing a device on the market, the manufacturers, authorised representatives and importers shall submit a registration in EUDAMED. The competent authority then obtains a single registration number (‘SRN’) and issue it to the manufacturer, the authorised representative or the importer. The manufacturer can use the SRN when applying to a notified body for conformity assessment and for accessing EUDAMED.
Until EUDAMED is fully functional:
- The system may be used on voluntary basis for the registration of manufacturers, authorised representatives and importers.
- The manufacturers, authorised representatives and importers should consider national provisions related to their registration.
Summary of safety and performance
For class C and D IVD devices (other than devices for performance studies), the manufacturer shall draw up a summary of safety and performance, which shall be made available to the public via EUDAMED.
Until EUDAMED is fully functional:
- The SSP must still made available to the public upon request without undue delay, or the manufacturer shall specify where it is available to the public.
- The system may be used on voluntary basis for the upload of the SSP.
Identification number and list of notified bodies
The European Commission shall make a list of the bodies notified under Regulation (EU) 2017/746, accessible to the public via NANDO and via EUDAMED.
Until EUDAMED is fully functional:
- The information continues to be a made available via NANDO.
Certificates of conformity
The notified body shall enter in EUDAMED any information regarding the certificates issued, and that information shall be accessible to the public.
Until EUDAMED is fully functional:
- Certificates will be made available upon request or will be uploaded in the national system.
- The system may be used on voluntary basis for the upload of the certificates even before the notice has been published.
Periodic safety update report (PSUR)
Manufacturers of class D devices shall submit PSUR by means of the EUDAMED.
Until EUDAMED is fully functional:
- Manufacturers should deliver the PSURs to the notified bodies by appropriate means, such as secure email.
- Notified bodies should provide the PSURs and corresponding evaluations to the manufacturers.
- Notified bodies should make the PSURs available upon request to the competent authority.
Reporting of serious incidents and field safety corrective actions
Until EUDAMED is fully functional:
- Manufacturers should report serious incidents and field safety corrective actions to the respective national vigilance systems.
- The new Manufacturer Incident Report (MIR) form has already been adapted to IVDR requirements and should be used accordingly.
- The current Filed Safety Corrective Action (FSCA) form should be used (any additional information required under the IVDR may be added to the general comments section of the form).
- The current Periodic Summary Report (PSR) Form should be used (the additional information required under the IVDR may be added to the general comments section of the form).
Trend reporting
Manufacturers shall report, through EUDAMED, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis.
Until EUDAMED is fully functional:
- Manufacturers must submit trend reports to the respective national vigilance systems.
- The current Trend report form should be used until its updating for IVDR compliance.
Analysis of serious incidents and field safety corrective actions
The manufacturer shall provide a final report to the competent authority setting out its findings from the investigation by means of the EUDAMED. The report shall set out conclusions and where relevant indicate corrective actions to be taken. The manufacturer shall enter the field safety notice in the EUDAMED through which that notice shall be accessible to the public.
Until EUDAMED is fully functional:
- Manufacturers should submit the final report to the respective national vigilance system.
- Manufacturers should submit the field safety notices to the respective national vigilance systems.
- The competent authorities should make these field safety notices publicly available to the public in accordance with national legislation.
Information regarding performance studies
Application for performance studies
The sponsor of a performance study shall submit an application to the Member State(s) in which the performance study is to be conducted. The application shall be submitted through the EUDAMED, which shall generate a Union-wide unique single identification number for the performance study.
Until EUDAMED is fully functional:
- The application should be made via the respective national procedures.
- The update and notification of information should also be via the national procedures.
- The European Commission should publish a list of national contact points for submission on their website.
Performance studies of CE marked devices
Until EUDAMED is fully functional:
- The notification should be made via the national procedures.
Substantial modifications to performance studies
Until EUDAMED is fully functional:
- The notification should be made via the national procedures.
Information of the end, temporary halt or early termination of a performance study
Until EUDAMED is fully functional:
- The communication and the upload of relevant information should be via the national procedures
- The competent authorities share and publish the PS reports and the respective summary reports via a publicly available CircaBC directory.
Coordinated assessment procedure for performance studies
Through the EUDAMED, the sponsor of a performance study to be conducted in more than one Member State may submit a single application that is transmitted electronically to all Member States concerned.
Until EUDAMED is fully functional:
- In the absence of EUDAMED, the coordinated assessment procedure is not possible.
- The procedure is mandatory as of 27 May 2029. Prior to that, the procedure is voluntary as decided by the Member States willing to participate.
Recording and reporting of adverse events during performance studies
The sponsor shall report through EUDAMED: any serious adverse event that has a causal relationship with the device, the comparator or the procedure or where such causal relationship is reasonably possible; any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate; any new findings in relation to any event previously stated.
Until EUDAMED is fully functional:
- The reporting should take place via the national procedures.
References:
- EUDAMED Timeline – The European Commission planning – June 2022.
