How to submit
You are required to register your clinical investigation with a medical device before submitting your research file to the review committee. You may register your investigation by completing the ABR form (version May 2021) in ToetsingOnline.
How to submit your research file to the review committee depends on under which legal framework your clinical investigation falls. Below is an explanation of how to submit your research file for each legal framework.
Clinical research in the context of conformity purposes (MDR article 62/74.2)
For clinical research in the context of conformity purposes (MDR article 62/74.2) the research file is first validated by CCMO.
After a positive decision on the validation, CCMO will transfer your file to the review committee (accredited MREC or CCMO) for assessment. CCMO will transfer your file to the review committee of your preference. If you did not indicate a preference for a review committee, CCMO will assign your file to a review committee.
In ToetsingOnline you can only select CCMO as review committee for your file. After validation, CCMO will adjust the review committee in ToetsingOnline.
You are required to submit your research file digitally to CCMO. Please consider the following:
- Digital signature
The obligation to sign the cover letter with a wet signature has been suspended. Instead, a digital or scanned signature of the submitting party will suffice.
- Digital submission
Please submit your research file by email to CCMO at firstname.lastname@example.org:
- State the file number (NL number) listed on the ABR form in your email;
- Explain in your email that it concerns a primary submission of a clinical investigation for conformity purposes;
- Do you need to send several emails due to the size of the documents? Then please use the same subject for each email and add a serial number;
- In the first email please state how many documents you will be submitting in all. This ensures that CCMO can check quickly whether all attachments are present.
Other clinical investigations (MDR article 82) or post-market clinical follow-up investigations (MDR article 74.1)
For other clinical investigations (MDR article 82) or post-market clinical follow-up investigations (MDR article 74.1), you may submit a file directly to the MREC of your choice. Please follow the instructions of the MREC concerned.
Coding and naming of documents
Your dossier will be checked for completeness in accordance with the format of the standard research file. Therefore, it is important to use the correct coding and naming for your documents in order to ensure a successful submission. Always start the file name with the two characters (letter + number) of the relevant section of the standard research file.
You are also required to give all file names a version or date. If you fail to do so, your application may not be accepted and will be returned.