Essentials of European Medical Device Regulatory Affairs

Clinical evaluation for initial CE-marking

Clinical evaluation is required for the conformity assessment process leading to CE-marking and placing the device on the market The purpose is to  Document that there is sufficient clinical evidence to demonstrate conformity with the GSPRs covering clinical performance and clinical safety  Identify aspects that need to be addresses systematically during post-market surveillance (PMS) e.g. in PMCF studies  Aspects include; estimation of residual risks and uncertainties regarding long-term performance and safety with wide-spread use

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Clinical Evaluation MEDDEV 2.7.1 (rev 4) & MDR

Clinical evidence

Clinical evaluation

Clinical data

The clinical data and clinical evaluation report pertaining to a device

A methodologicallysound / systematic and planned ongoing process to continuously generate, collect, analyse and assess the clinical data pertaining to a device To verify the safety and performance, including clinicalbenefits, of the device when used as intended by the manufacturer

Clinical investigationof the device concerned

Sufficient amount and quality to allow a qualified assessment of whether the device achieves the intended clinical benefit(s) and safety, when used as intended by the manufacturer

Clinical investigationor other studies reported in the scientific literature, of a similardevice for which equivalence to the device in question can be demonstrated

Peer reviewed scientific literature (published and/or unpublished) on other clinical experience of either the device in question or a similardevice for which equivalence can be demonstrated

Data from the manufacturer’s post-market surveillance system, in particular post-market clinical follow-u p

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