How to submit

Performance studies (IVDR article 58/70(2))

For IVD performance studies (IVDR article 58/70(2)), first of all the research file is validated by CCMO.

After a positive validation, CCMO will transfer your file to the review committee (accredited MREC or CCMO) of preference for further assessment. 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:

• Please submit your file at devices@ccmo.nl; 
• State the file number (NL number) listed on the ABR form in your email;
• Explain in your email that your primary submission concerns an IVD performance study;
• 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 all in all. This ensures that CCMO can check quickly whether all attachments are present.

Notification companion diagnostic performance studies with leftover samples only

For performance studies with companion diagnostics a specific provision has been included in the IVDR (IVDR article 58(2)). This means that these performance studies must be reviewed by an accredited review committee. An exception applies if only leftover samples are used; in that case a notification to the CCMO at devices@ccmo.nl is sufficient.

Post-market performance follow-up (IVDR article 70(1))

For post-market performance follow-up studies with additional invasive and burdensome procedures (PMPF, IVDR article 70(1)), you may submit your file directly to the MREC of your choice. Please follow the instructions of the MREC concerned. If CCMO serves as review committee, please submit your file to tc@ccmo.nl .

Coding and naming of documents

Your file 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.