Because the electronic system referenced to in Article 73 (Eudamed) will not be ready and completely functioning on the MDR’s effective date, this guideline covers the processes for safety reporting in clinical research in the absence of Eudamed.
MDCG 2020-10 rev 1 describes the reporting modalities for Serious Adverse Events (SAEs) and contains a summary tabulation reporting format.
Medical device safety reporting in clinical studies with medical devices must follow the guidelines in Article 80 of Regulation (EU) 2017/745, Medical Device Regulation (MDR).
By using the electronic system mentioned in MDR Article 73, the sponsor is required to immediately disclose all of the following to each Member State where the clinical investigation with medical technology is being conducted:
- any serious adverse event that is linked to the investigational device, the comparator, or the investigation procedure or where such a connection is conceivably possible;
- any device flaw that could have resulted in a serious adverse event if the right steps hadn’t been taken, an intervention hadn’t been made, or the situation had been worse;
- any additional information on an event mentioned above
The adverse event reporting period must consider how serious the event was. The clinical trial sponsor may submit an initial report that is partial and then a complete report as needed to guarantee timely reporting.
The reporting requirements of MDR Article 80(5) and (6) apply to post-market clinical follow-up (PMCF) investigations of MedTech CE-marked products used within the intended use covered by the CE-marking. This implies that the vigilance measures outlined in MDR Articles 87 to 90, as well as the actions enacted in accordance with Article 91, will apply to PMCF clinical studies.
However, MDCG 2020-10 Revision 1 is still applicable to PMCF clinical investigations since the reporting of significant adverse events with a causal link to the previous investigational device must adhere to the clinical investigation reporting requirements stated in EU MDR 2017/745 Article 80.
MDCG 2020-10 Revision 1 provides the guidelines required for the establishment of Safety reporting SOPs, Safety reporting plans, and Clinical Investigation plans for MedTech Manufacturers, sponsors and CROS that develop clinical research activities with medical devices.
