Guidance for Notified Bodies, Distributors and Importers on Certification Activities in Accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

In August 2021 the Medical Device Coordination Group (MDCG) published guidance of MDCG 2021-23.

Article 16(3) of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) introduces requirements on the quality management system to be established by distributors and importers carrying out any of the activities mentioned in points (a)2 and (b)3 of Article 16(2) concerning relabeling and repackaging of devices.

Article 16(4) of the MDR / IVDR provides for a notified body to certify that the quality management system of the distributor or importer complies with the requirements laid down in the abovementioned Article 16(3).

Notified bodies providing such certifications are required to be designated for the type of devices that are subject to activities mentioned in points (a) and (b) of Article 16(2). However, such certification activities to be performed by them are not related to conformity assessment activities carried out to certify manufacturer’s devices according to either Article 52 of the MDR or Article 48 of the IVDR. Therefore, notified bodies need to establish the assessment activities necessary in order to certify the quality management system of a distributor or importer intended to relabel and / or repackage a device. In addition, it is also important to get clarity on the elements to be addressed by distributors and importers in the abovementioned quality management system.

This guidance document is mainly focused on activities performed by notified bodies, providing clarification on the quality management system they are expected to assess.

Read the pdf 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /