MDR - annex IX - Chapter 1 - article 1

Original text

Expert opinion

Quality Management System

1. The manufacturer shall establish, document and implement a quality management system as described in Article 10(9) and maintain its effectiveness throughout the life cycle of the devices concerned. The manufacturer shall ensure the application of the quality management system as specified in Section 2 and shall be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as specified in Section 3


The manufacturer of a medical device is obliged to establish, document and implement a Quality Management System (QMS). Even thought the Medical Device Regulation MDR 2017/745 does not explicitly name the ISO 13485, it is the QMS international standard to work according to.

Further, the QMS has to be kept up-to-date and is subject to audit. Thus, the audit will most likely following ISO 13485, and having it not implemented will add additional risk to the audit.


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