In this video the major changes to the regulatory submission in the Netherlands of clinical investigations is given.
These 6 key changes to the regulatory application in the Netherlands under the MDR are:
The CCMO will be the competent authority for clinical investigations. A separate notification to the Health and Youth care Inspectorate (IGJ) is no longer obligatory.
A European portal, Eudamed, is under construction. In this portal, all relevant information concerning medical devices is registered, including the registration of clinical investigations. Eudamed is currently expected to be fully functional in 2022. In the meantime, clinical investigations in the Netherlands are submitted via the ToetsingOnline portal.
There are minor changes in the application dossier. One of the new documents that needs to be submitted is the clinical evaluation plan (CEP) in case of clinical investigations for conformity assessment, for instance, in the framework of product development and obtaining a CE-mark. For registration in the forthcoming Eudamed, a submission form compliance with details of the clinical investigation is under construction and is required as of May 26th 2021.
The Dutch model of the Investigational Medical Device Dossier, the IMDD, has been adapted in December 2020 to comply with the requirements of the MDR.
There are no other major differences in the assessment criteria as compared to the current practice. However, the conditions for conducting non-therapeutical clinical investigations with minors or incapacitated subjects are more restrictive than the conditions for clinical trials under the Clinical Trial Regulation.
A coordinated assessment procedure with all member states in which the clinical investigation will be conducted, will be possible in the near future. Which will be a mandatory procedure as of May 2027 as described in the MDR article 78.