Has your study into a medical device been approved by an accredited MREC prior to May 26, 2021? If so, the study may continue in line with the applicable legislation prior to May 26, 2021, with the exception of the safety reports; as of May 26, 2021 these must comply with the provisions in the EU Medical Devices Regulation (MDR) (MDR article 80).
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.
Current submissions submitted prior to May 26, 2021
Studies into medical devices submitted to an accredited MREC or CCMO prior to May 26, 2021, but for which the assessment has not yet been completed by May 26, 2021, must meet the provisions in the MDR. There is no transition period. The following procedures apply to such studies:
- Such investigations involving medical devices must meet the requirements of the MDR and the Medical Devices Act [Wet medische hulpmiddelen].
- The review committee (accredited MREC or CCMO) assesses under which legal framework of the MDR (article 62, 74 or 82) the investigation falls.
- Investigations in the context of conformity purposes (MDR article 62 or 74.2) must be submitted to CCMO for validation as of May 26, 2021. CCMO validates and assigns the investigation to the accredited MREC which has already been assessing the investigation. Does it concern a medical device class IIa (invasive), IIb (invasive) or class III? If so, the investigation is transferred to another accredited MREC if the original MREC was not one of the eight MRECs attached to an academic medical centre or the MEC-U. Assessment then follows in accordance with the provisions in the MDR.
- Post-market clinical follow-up (MDR article 74.1) or other (MDR article 82) investigations do not have to be resubmitted for assessment after May 26, 2021. The MREC that assessed the investigation can continue to do so. However, the MREC will assess whether the investigation meets the requirements of the MDR. The MREC will request additional information if necessary.