Clinical Evaluation

Clinical Investigation Under EU 2017/745/ MDR

The European Union’s Medical Device Regulation (MDR) 2017/745 establishes a comprehensive framework for the clinical evaluation of medical devices, ensuring their safety and performance before market introduction. Central to this framework is the categorization of clinical investigations, each serving distinct purposes in the device development lifecycle. The primary types of clinical investigations include Exploratory, Observational, …

MDCG 2020-5 Clinical Evaluation – Equivalence

MDCG 2020-5, issued by the European Commission (EC), is a guide that explains how to show that a medical device is equivalent to another with a CE mark. This guide is very important because proving equivalence in the EU is complex. Moreover, the EU MDR and MEDDEV 2.7/1 Rev. 4, a guide on clinical evaluation, …