The Regulation (EU) 2017/745 frames medical devices in Europe.It enables the implementation of a quality management system (QMS) in a medical device context, for regulatory purposes. This annex is a necessary ste^for the harmonization process of 13485. It includes Annexes ZA and ZB that link the standard to the requirements of Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro diagnostic medical devices). Requirements for regulatory purposes) is available. Amendment A11 to ISO 13485 ( Medical devices.