There are many different requirements with which in vitro diagnostic manufacturers have to comply in order to place products on the market. At the core of most of these requirements is a fundamental need to have a good quality management system (QMS) in place. There are several regulations and standards that focus on QMS requirements, but this paper primarily examines the QMS requirements in the new In Vitro Diagnostic Device Regulation (IVDR) 2017/7462 which has entered into force as of May 26, 2017 and will serve as the basis for access to the European market. Complying with the requirements of BS EN ISO 13485:2016 will largely fulfil those requirements established in the IVDR.
