Clinical investigations and performance studies
Before a manufacturer is allowed to place a medical device or in vitro diagnostic medical device (IVD) on the market, it must first conduct a clinical evaluation. For medical devices, this is a clinical investigation and for an in vitro diagnostic medical device this is a performance study.
Statutory requirements have been established for the performance of clinical investigations with a medical device and performance studies for IVDs Manufacturers are not permitted to market these devices commercially for investigational purposes. They may only use the devices to evaluate compliance with the statutory requirements and to collect information about their performance.
Registration of clinical investigations with medical devices
The Central Committee on Research Involving Human Subjects (Centrale Commissie Mensgebonden Onderzoek, CCMO) is the (sole) competent authority for all registrations (notifications) relating to clinical investigations with medical devices. This means that the CCMO processes the notifications for these investigations. In the past, before 1 October 2020, these duties were carried out by the Health and Youth Care Inspectorate.
Manufacturers are required to register any clinical investigation involving a medical device with the CCMO.
In the case of a clinical investigation with medical devices that had already been registered with the Health and Youth Care Inspectorate before 1 October 2020, any serious adverse events (SAEs), suspension or premature ending of an investigation must likewise be reported to the CCMO.
Registration of performance studies with in vitro diagnostic medical devices
As of 26 May 2022, the situation for studies into or with in vitro diagnostic devices (IVDs) has changed. Under the new IVDR, the CCMO must, in many cases, be notified of any performance study with IVDs – this mainly relates to studies that involve risks to the test subjects. The IVDR set outs the various cases in which this does or does not apply.
Prior to 26 May 2022, under the IVD Directive, performance evaluations with IVDs did not have to be registered, unless the design of the study gave cause to do so on the grounds of the Medical Research Involving Human Subjects Act (Wet medisch-wetenschappelijk onderzoek met mensen, Wmo).
More information and questions
- For more information, please visit the CCMO website: www.ccmo.nl (English)
- You can send questions about clinical investigations with medical devices to devices@ccmo.nl