Information EU Medical Device Regulation available on CCMO website
On May 26, 2021, the EU Medical Device Regulation (EU no 2017/745, MDR), will come into effect. The MDR contains specific rules for the submission, review and conduct of clinical investigations with medical devices. All required information for investigators about the MDR is available on a theme page on CCMO’s website.
Due to circumstances the information is currently only available in Dutch. However, an English translation of all the information is in progress and will be available as soon as possible.
The theme page consists of five sections:
- Legislation, regulations, directives and guidances
- Standard research file
- Primary submission
- During and after the investigation
- Appeals and objections
These web pages focus specifically on the requirements of the MDR regarding clinical investigations with medical devices. Here you will find all the information you need for the submission, review and conduct of your study. The standard research file is specifically designed for clinical investigations with medical devices. In the section During and after the investigation, you will find information for studies reviewed under the MDR but also prior to the MDR.
Validation by CCMO
The MDR stipulates that clinical investigations with medical devices for conformity purposes (MDR article 62 or 74.2) must be validated before a review committee can review the study. In the Netherlands, this validation is done by CCMO. CCMO checks whether the clinical investigation falls within the scope of the MDR and whether the research file is complete.
As of May 26, 2021, all safety reports for clinical investigations with medical devices must comply with the provisions in the MDR. This also applies to research approved by an accredited MREC or CCMO before May 26, 2021.
In order to determine which committee should review your study, you may use the Committee Finder. This tool has been updated on the requirements in the MDR.
The ToetsingOnline submission portal will be updated on May 25, 2021, to meet the requirements of the MDR. You are required to register a study that falls within the scope of the MDR in the new release of ToetsingOnline.
Research involving pregnant or breastfeeding women
As of May 26, 2021, the amended Central Review Decree will also come into effect. This stipulates that from this date on clinical investigations with medical devices in pregnant or breastfeeding women will be reviewed by CCMO.
Guidance for MRECs
The guidance for MRECs has been updated to reflect the current state of affairs. In addition, some textual changes have been made.
Questions or comments?
If you have questions or comments about the information on our website regarding the MDR, please let us know by sending an email to email@example.com stating 'Information website MDR'. Your response will help us to improve the information provided on our website.