Essentials of European Medical Device Regulatory Affairs

When to conduct a Clinical evaluation ?

• Clinical evaluation is an ongoing process conducted throughput the life cycle of a medical device • First performed during early development • Then performed during the conformity assessment process • Subsequent post-marketing evaluations to ensure continued conformity • New clinical safety data • New clinical performance data • The continued evaluation is essential for identifying further risks that occur with use of the device and may result in labelling changes

The Organisationfor Professionals inRegulatory Affairs

Clinical evaluation undertaken for the development of a medical device Premarket research and development are guided by clinical evaluation and risk management Manufacturers carry out clinical evaluations to;  Define needs regarding clinical safety and clinical performance of the device  In the case of possible equivalence to an existing device, evaluate if clinical data is available and determine equivalence for additional information  carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary and if so, define the study design As the initial clinical evaluation identifies the questions to be answered by a clinical investigation the clinical evaluation process should commence in advance of any clinical investigation

The Organisationfor Professionals inRegulatory Affairs