EU Regulation 2017/745 on medical devices applies from 26 May 2021. The MDR repeals Directives 90/385/EEC and 93/42/EE, respectively on AIMD and medical devices. The scope and emphasis on clinical evaluation is now more comprehensive under the MDR than under the Directives.
Clinical evaluation ensures that safety and performance of a medical device is based on sufficient clinical evidence throughout its life on the market. Eclevar has extensive experience in the field of clinical evaluation: our team of medical writers is eager to support you.