A manufacturer must carry out a clinical evaluation before it is allowed to market a medical device. Clinical trials may be part of that clinical evaluation.
Statutory requirements can be imposed on the performance of clinical trials with a medical device that cannot yet be marketed commercially for a specific purpose. The Inspectie Gezondheidszorg en Jeugd (IGJ, Health and Youth Care Inspectorate) supervises compliance with these rules.
The CCMO is responsible for notifications of clinical trials with medical devices
Since 1 October 2020, the Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek, CCMO) has been the (sole) competent authority for all notifications relating to clinical trials with medical devices. This shifting of tasks is laid down in the the Medical Devices Decree and the Active Implants Decree (Besluit medische hulpmiddelen en Besluit actieve implantaten).
As competent authority, the CCMO has processed the notifications for these trials since 1 October 2020, rather than the Health and Youth Care Inspectorate (IGJ) as used to be the case.
Consequently, manufacturers have been required to register clinical trials with a medical device with the CCMO.
The CCMO must also be notified of serious adverse events (SAEs) and the suspension or the (premature) ending of a clinical trial that was registered with the IGJ.
The situation has not changed concerning research into or involving in-vitro diagnostic devices (IVD). Under the IVD Directive, a performance evaluation with IVDs is not required unless the structure of the clinical trials gives cause to do so on the grounds of the Medical Research Involving Human Subjects Act (Wet medisch-wetenschappelijk onderzoek met mensen, Wmo).
These tasks were shifted from the IGJ to the CCMO in anticipation of the Medical Devices Regulation (MDR), (EU) 2017/745, which has been applicable since 26 May 2021. The coming into effect of the MDR means that the rules for submitting, assessing, and performing clinical trials with medical devices have changed.