The Medical Devices Coordination Group (MDCG) released new guidance on alternative solutions until EUDAMED is fully functional: MDCG 2022-12
While this guidance document cites the IVDR, it is reasonable to apply the same expectations to the MDR.
There are no major surprises. Highlights from the guidance include:
Economic Operator and device registration:
- Should continue to follow the old Directives / provisions required by the individual national competent authorities until EUDAMED is in force
- These modules are already available in EUDAMED, and industry may voluntarily register; however, voluntarily use of EUDAMED does not exempt companies from the national competent authority’s registration requirements
Summary of safety and performance:
- Industry may voluntarily choose to use EUDAMED, as the functionality is currently available
Notified Body Designation, Identification, Monitoring and Changes:
- EU Commission to publish in NANDO, and
- Use the Communication and Information Resource Centre for Administrations, Businesses and Citizens (CircaBC), an online information sharing system already established by the EU Commission, for other related Notified Body communication
Application for Performance Studies, including modifications and adverse event reporting:
- Should take place per the individual Competent Authority’s requirements
Electronic System on Performance Studies:
- Per national competent authority’s existing processes, plus facilitated by teleconferences or an online platform such as CircaBC
Periodic Safety Update Report (PSUR):
- Manufacturer to deliver the PSUR to the Notified Body by secure means, such as email
- Notified Bodies to make them available to the Competent Authorities upon request
Reporting of serious incidents and field safety corrective actions:
- Manufacturers should report based on each individual Competent Authority’s national vigilance system
- Competent Authority communications with one another should occur through:
- IVDR devices – a secure directory in CircaBC
- IVDD devices – the existing Eudamed2 system
Trend Reporting:
- Manufacturers should submit trend reports to Competent Authorities via their respective vigilance systems
