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, 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, …
Performance evaluation (PE) is an important part of design validation and technical documentation required to place an in vitro diagnostic device (IVD) on the EU market. Article 56 of the EU 2017/746 In Vitro Diagnostics Regulation (IVDR) requires manufacturers to prepare a performance evaluation report to demonstrate the safety and performance according to the manufacturer’s …