May 2021: Netherlands Regulatory Update

Information Regarding EU Medical Devices Regulation Available on the CCMO Website

The Central Committee on Research Involving Human Subjects (CCMO) announced the availability of a special theme page for clinical research on medical devices on May 20, 2021. Also, the ToetsingOnline submission portal is expected to be adapted to the requirements of the MDR on May 25th. Research that falls within the scope of the MDR must be registered in the new release of ToetsingOnline.

Until the European portal, Eudamed is functional all research involving medical devices must be submitted via ToetsingOnline. The study must be registered by filling in the ABR form (version May 2021) online in ToetsingOnline. Also, to register in the future Eudamed, a Eudamed form has been made available, which is mandatory from May 26, 2021, for clinical investigations that fall under Article 62 or 74 of the MDR.

Additionally, the requirements for reporting the results of a clinical study with medical devices are provided as below:
  1. Results of research for conformity purposes (MDR article 62 or 74.2) or post-market clinical follow-up (PMCF) investigations (MDR article 74.1):
    • As per MDR, the sponsor must submit a clinical study report and a summary of results for the layperson within one year of the end of the study.
    • For prematurely ended studies, the investigation report and the lay summary must be submitted within 3 months.
    • As soon as Eudamed is operational, the sponsor must upload the results of the investigation into Eudamed and the investigation report and the lay summary will be made public via Eudamed.
    • However, as long as Eudamed is not operational, the research report and lay summary must be immediately submitted to the CCMO (along with the review committee) via [email protected].
  2. Results of other clinical research (MDR article 82):
    • Summary results must be submitted within one year of the end of the study to CCMO.
    • The results of the research will be published in the CCMO register 15 days after upload unless the client has objected to this with reasons.

For more information on this, please refer to the post on the CCMO website here.

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