Assessment time limits for clinical investigations with medical devices | The Central Committee on Research Involving Human Subjects

Different deadlines are used for the assessment of clinical investigations with medical devices for the primary submission and for amendments. Please see the table below to find out which time limit applies to your investigation.


Type of assessment	Clinical investigation framework	Medical device class	Assessment deadlines*
Primary assessment	MDR 62/74.2	Class IIa invasive Class IIb invasive Class III	Maximum 45 (+20 in case of expert consultation) calendar days + clock stop
		Class I Class IIa non-invasive Class IIb non-invasive	Maximum 2 x 56 calendar days + clock stop
	MDR 74.1/82	All	Maximum 2 x 56 calendar days + clock stop
Assessment amendment	MDR 62/74.1/74.2	All	Up to 38 (+ 7 if expert opinion) calendar days + clock stop
	MDR 82	All	Maximum 2 x 56 calendar days + clock stop

* These are calendar days. If a term ends on a weekend or public holiday, the next working day is the last day of the term.

Clock stop

The MREC or CCMO can call a clock stop to request further information within the set terms. The MREC or CCMO sends a message to this effect to the submitting party. Upon receipt of the additional information the deadline starts running again.

Term monitoring in the Research Portal is not specifically set for MDR and has a default deadline of 56 days for both validation and the assessment of primary submissions and amendments.