What is assessed by whom?
As clinical investigations with medical devices must be assessed by an authorised review committee (accredited METC or CCMO), the review committee is required to include an expert on medical devices.
A limited number of review committees are authorised for clinical investigation with high-risk medical devices in the context of conformity purposes (see table below).
Clinical investigation framework* | Class of medical device | Review committee** |
---|---|---|
Clinical investigation for conformity purposes |
Class I and non-invasive Class II (a & b) | accredited MREC or CCMO |
Class III and invasive Class II (a & b) |
|
|
Clinical investigation for PMCF with invasive and burdensome procedures |
All classes | accredited MREC or CCMO |
Clinical investigation with a different purpose |
All classes | accredited MREC or CCMO |
* For the framework for clinical investigations see Clinical investigations: definition and framework.
** The review committee is required to include an expert on medical devices.
To select an authorised MREC you may use the online tool Committee Finder.
For clinical research that may only be assessed by CCMO see Review by CCMO.