MDStudy object

IMD is defined as 'any device that has been manufactured for use by a qualified medical practitioner or a person authorized to conduct clinical investigations in an adequate human clinical environment, in order to evaluate the performance of the device under normal conditions of use or any undesired side effect under normal conditions of use and to evaluate whether such effect constitutes acceptable risk when weighed against the intended performance of the medical device' (Regulation On Medical Device Clinical Trials 2014).

• Clinical trial is defined as 'the systematic researches or studies conducted on volunteers in order to evaluate the safety, efficacy or performance of the medical device, at one or more than one centre'

• Observational medical device study is defined as 'a study in which device or devices bearing “CE” marking in compliance with the Medical Device Regulations are used spontaneously in line with the purpose of use specified by the manufacturer, and the clinical safety or performance data in relation with the medical device are gathered' (Regulation On Medical Device Clinical Trials 2014).