You are required to inform the review committee (accredited MREC or CCMO) about the definite starting date of the IVD performance study.
In general, the starting date of the study in the participating country is the date on which the first subject signs the informed consent form. However, you may include a different date in your study protocol.
The start of a performance study has to take place within two years of the date of approval of your study. Has this period expired? Please contact the review committee with a motivated request to extend the validity of the decision.
The assessing review committee processes the definite starting date in ToetsingOnline.