Reporting of adverse events that occur during clinical investigations

Safety reports relating to clinical investigations of medical devices should be submitted to the JAZMP in accordance with the guidance: MDCG 2020-10/1 Safety reporting in clinical investigations of medical devices under the Regulation (EU) 2017/745.

The MDR identifies serious adverse events and device deficiencies and, in accordance with Article 80(2) of the MDR, the sponsor must report:
  • any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation 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 referred to in points (a) and (b).

The MDCG 2020-10/1 document provides further guidance on the reporting of serious adverse events that occur during a clinical investigation, including timelines for reporting to national competent authorities. Until the EUDAMED CI module is made available, the JAZMP expects sponsors to submit the relevant reports on adverse events by email to: , using the excel template MDCG 2020-10/2 Appendix: Clinical investigation summary safety report form.

The MDR sets out transitional provisions for clinical investigations that have started to be conducted before 26 May 2021 or for which an application for a clinical investigation has been submitted in accordance with the MDD. These investigations may continue to be conducted after the date of application of the MDR; as of 26 May 2021, however, the reporting of serious adverse events and device deficiencies must be carried out in accordance with the requirements of the MDR.

For substantial modifications of clinical investigations approved under the MDD, the MDD process for authorisation of the modification must be followed even after 26 May 2021, requiring the submission of the MedPri-MP-obr04 Application for notification of a modification of a clinical investigation of a medical device.

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