Assessment deadlines for IVD performance studies
For IVD performance studies, different deadlines are used for primary submission and for amendments. Please see the table below to find out which deadline applies to your study.
| Type of assessment | Performance study frame | Assessment deadlines* |
|---|---|---|
| Primary assessment | IVDR 58/70(2) | Maximum 45 (+20 in case of expert consultation) calendar days + clock stop |
| IVDR 70(1) | Maximum 2 x 56 calendar days + clock stop | |
| Assessment amendment | IVDR 58/70(1)/70(2) | Up to 38 (+ 7 if expert consultation) calendar days + clock stop |
* These are calendar days. If a term ends on a weekend or public holiday, the next working day is the deadline.
Clock stop
The MREC or CCMO can call a clock stop to request further information within the set deadlines. The MREC or CCMO sends a message to the submitting party to this effect. Upon receipt of the additional information submitted in the Research Portal the remaining deadline is reestablished. Term monitoring in the Research Portal is not specifically set for IVDR and has a default deadline of 56 days for both validation and the assessment of primary submissions and amendments.