Temporary solutions until Eudamed becomes available
Implementation of the new EU database for medical devices, Eudamed, is delayed. Eudamed consists of several modules, which will be made available on a gradual basis as soon as they are functional. We do not know when the Eudamed module for clinical investigations will be made available. NoMA provides temporary solutions for the processes that are dependent on Eudamed until further notice.
- All communication between the sponsor and NoMA will be via email, as described on our website. This includes applications, notifications, safety reporting, substantial modifications etc.
- Clinical investigations performed in more than one EU/EEA member state: The coordinated assessment procedure for clinical investigations is voluntary until 2027. Voluntary participation will not be possible until Eudamed is available. NoMA has not yet decided if we will participate in the coordinated assessment procedure before it becomes mandatory in 2027. All applications will be processed according to national procedure as described on our website until further notice.
- Unique single identification number (SIN, MDR article 73) for clinical investigations will not be issued until Eudamed is available.
- The summary submitted by the sponsor to NoMA at the end of the clinical investigation will be published.
Ongoing clinical investigations started prior to 26th May 2021
Clinical investigations started prior to 26th May 2021 shall be conducted according to the previous regulation. There will however be new requirements to safety reporting for these studies.
Starting 26th May 2021, the sponsor must report serious adverse events (SAEs) in accordance with MDR Article 80. The safety reporting must be in line with the guidance issued by the MDCG using the designated form:
The guidance MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745 provides detailed information about the new requirements.
Appendix: Clinical investigation summary safety report form. The completed form must be submitted to firstname.lastname@example.org.