Registration of clinical investigations with medical devices with the CCMO as of 1 October 2020
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). Previously, the competent authority for this task was the Health Care and Youth Inspectorate (IGJ).
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). Previously, the competent authority for this task was the Health Care and Youth Inspectorate (IGJ). The fact that manufacturers now have to register with the CCMO is due to the amendment of the Medical Devices Regulation (MDR), which will enter into force on 26 May 2021. In order to prevent confusing situations, it has been decided to transfer the registration procedure from the IGJ to the CCMO ahead of 26 May 2021. See the collective decree of the Ministry of Health, Welfare and Sport 2020 (in Dutch).
The application procedure will at this stage not change in terms of its content. Accordingly, clinical investigations using medical devices must be registered before the start of the investigation. The objectives of clinical investigations are to verify the performance of the devices in conformity with the requirements and to determine any undesirable side-effects under the normal conditions of use. The eventual purpose is to obtain the CE marking. A clinical investigation with a medical device that already bears the CE marking must also be registered if the purpose of the investigation falls outside of the scope of the intended purpose of the medical device (i.e. new indication). Furthermore, the obligation to register with the CCMO also entails reporting Serious Adverse Events (SAEs) and reporting the ending or the premature ending of the study. The registration statement must contain, among other things, the identifying data of the medical device, the investigation plan and the statement confirming that the device is in conformity with the essential requirements. Following 26 May 2021, amendments will be made to the documentation that must be provided.
In order to easily find the competent authority for the registration of clinical investigations, there is an online tool called Committee Finder. The Committee Finder has been updated in accordance with the amendments in the registration procedure for a clinical investigation using a medical device.
Please do not hesitate to contact our Life Sciences Team in case you have any questions about the application procedure or the Medical Devices Regulation.