Procedure for Clinical study

We are asked to have a procedure for clinical studies. Does anyone have an example of what the content of this procedure should be?

 

This isn't exactly in my wheelhouse but maybe it gets the discussion going. You may need to provide more context but there is a renewed emphasis on postmarket surveillance, which includes the need for some form of clinical evaluation (actually, the clinical evaluation should start before hitting the market). If you go to the MEDDEV guidance pae (http://ec.europa.eu/growth/sectors/medical-devices/guidance/#meddevs), there are several documents that may be applicable (again, depending on context):

• MEDDEV 2.7/1 rev.4 Clinical evaluation: Guide for manufacturers and notified bodies
• MEDDEV 2.7/4 Guidelines on Clinical investigations: a guide for manufacturers and notified bodies
• MEDDEV 2.12/2 rev.2 Post Market Clinical Follow-up studies

Maybe this gets you started or maybe it helps frame the conversation.

 

We are in the middle of an audit for annex 2.3 and asked about if we have a top level procedure for clinical studies.

 

ISO 14155:2011:Clinical investigation of medical devices for human subjects -- Good clinical practice