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Assessment time limits for clinical investigations with medical devices

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.