Devices Subject to Clinical Investigation

Medical Device Regulation (MDR)

REGULATION (EU) 2017/745, 5 April 2017 on medical devices


Devices requiring clinical investigations on the European population

Except for the cases listed below, implantable and Class III devices must undergo clinical investigations that represent the European population:

(a) The device was legally placed on the market or put into service under Directives 90/385/EEC or 93/42/EEC, and its clinical evaluation:
  • (i) is based on sufficient clinical data, and
  • (ii) complies with the common specifications (CS) specific to the clinical evaluation of the device. or
(b) The device is a suture, staple, dental filling, dental brace, dental crown, screw, wedge, plate, wire, pin, clip, or connector, and its clinical evaluation is based on sufficient clinical data while complying with such common specifications, if available.


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