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MDCG Guidance for NBs, importers, & distributors: QMS certification for relabelling & repackaging

The MDCG Guidance provides an overview of activities, requirements, auditing, surveillance and changes and minimum content of the Certificates issued by a notified body.

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


This guidance is intended to provide assistance to notified bodies to implement requirements established by MDR and IVDR with regard to certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements.


This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body.


The quality management system should govern the structure, responsibilities, procedures, processes and management of resources required to implement the principles and actions necessary to achieve compliance with the provisions of Article 16(3) of the MDR / IVDR.


To view the points that is expected to cover and address from quality management system is detailed in the guidance.

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