Clinical investigations involving medical devices : (Mis)Match between registration and notification in the Netherlands
Klinisch onderzoek met medische hulpmiddelen : (Mis)match tussen registratie en notificatie in Nederland
08 June 2018, PDF |
36 pages |
van Elk M, Roszek B, Hegger I
RIVM Report 2017-0172
In order to show that medical devices are safe and functional, it is necessary to do research in humans (clinical trials). In order to ensure the safety of the trial subjects (healthy volunteers or patients) and the scientific quality of this type of research, before the trial starts a Medical Ethics Review Committee (MERC) evaluates it to make sure it has been designed properly. This committee also assesses the trial to see if it is acceptable from an ethical point of view. If a clinical trial is carried out on a medical device that does not carry the CE mark, the trial must also be submitted to the Dutch Health and Youth Care Inspectorate in formation (IGJ). This is known as the 'obligation to notify'.
Research carried out by the National Institute for Public Health and the Environment (RIVM) has shown that clinical trials are not always submitted to the IGJ. This could be because applicants are not aware of their obligation to notify, or because the clinical trial is only submitted when the study is actually starting. From 2015-2017, the number of notifications of clinical studies increased when compared with 2011-2013. This may be because the obligation to notify is now better recognised.
In recent years, the IGJ and the Central Committee on Research Involving Human Subjects (CCMO) have been working together to actively spread information about this legal obligation. Applicants to MERCs for clinical trials reported their sources of information about the obligation to notify as being the websites of the IGJ and the CCMO, part of standard procedures at their hospitals, and training courses for researchers.