Transitional arrangements
Has your IVD performance study been approved by an accredited MREC prior to May 26, 2022? If so, the study may continue in line with the applicable legislation prior to May 26, 2022, with the exception of the safety reports; as of May 26, 2022 these must comply with the provisions in the IVDR (IVDR article 76).
Detailed information on safety reporting can be found on Safety report. You are required to inform the MREC concerned of the new procedure for reporting serious adverse events (SAEs). This may be done through an annex to the protocol. A separate substantial amendment is not required. You may incorporate the changes regarding safety reports in the next substantial amendment of the research protocol.