Objection to negative validation
Are you the sponsor of an IVD performance study subject to IVDR article 58 or 70(2), and do you disagree with a negative validation by CCMO? In this case you may file an objection with the CCMO.
Before the review committee can start assessing the research file, CCMO must determine wether the IVD performance study is within the scope of the IVDR and determine if the submitted research file is complete. In the following situations CCMO may decide to carry out a negative validation:
- Your study does not fall within the scope of the IVDR,
- Your study does fall within the scope of the IVDR, but the research file is incomplete.
Interested parties may file an objection with CCMO to a decision of negative validation. This must be carried out within six weeks of the day on which the decision was announced.
Your objection must at least contain the following items:
- Your name and address,
- A description of the decision you are objecting to,
- A date,
- A signature,
- The grounds for the objection (the reasons why you do not agree with the CCMO decision).
Please send the notice of objection to email@example.com, citing 'Objection to negative validation' and the file number.
Essentially, CCMO has six weeks to rule on your objection. This period starts the day after the objection period of six weeks has expired. The CCMO may prolong this term by another six weeks.
Please note! The information above does not concern an objection to a CCMO decision on the assessment of a research file. Information on this can be found on the page Objection to a CCMO decision.