|Target Audience||Notified bodies, distributors and importers|
|Products concerned||MD & IVD|
MDR (EU) 2017/745
IVDR (EU) 2017/746
This guide is intended to assist NB in carrying out certification activities in accordance with articles 16(4), of Regulations (EU) 2017/745 and 2017/746.
It is also intended for distributors and importers performing relabelling and/or repackaging activities of devices (articles 16(2), points a and b of the Regulations), as it clarifies the quality management system (QMS) requirements to be implemented in order to meet the requirements of articles 16(3) of the Regulations.
This document lists the minimum QMS requirements with which the distributors and importers concerned must comply in order to be able to demonstrate compliance with the applicable requirements.
It also provides details of NB certification activities, including the conditions for conducting certification audits, the content and validity of certificates issued under articles 16(4) of the Regulations, and how to communicate changes that affect the validity of the certificate.
Information to follow : A future guide in the form of a Q&A is being planned to clarify other requirements of articles 16 of the regulations for distributors and importers.