News about GMP/cGMP

26.08.2021

MDCG: Guidance on repackaging and relabeling processes of devices

MDCG: Guidance on repackaging and relabeling processes of devices

This month, the Medical Devices Coordinating Group of the European Commission, MDCG, published a 7-page guideline for notified bodies, distributors, and importers of medical devices. It should provide a basis for the certification of quality management systems (QMS) related to repackaging and relabeling processes of medical devices according to MDR and IVDR.


It covers certification activities according to Article 16 (4) MDR/IVDR, requiring a profound QMS. This includes, for example, correctly translated and up-to-date documents, conditions that do not jeopardize the original condition of the product and, of course, that the packaging of the repackaged product is not defective and of poor quality. The QMS should further include procedures that ensure contractual agreements between all economic partners involved. Topics such as responsibilities, documentation, safety, corrective actions, traceability, on-site audits of premises should be clearly addressed. This document describes in detail how such a system is to be assessed and certified by a notified body.

The MDCG notes that a separate Q&A document is being developed to complement and address the implementation of other relevant requirements introduced for distributors and importers by Article 16 of the MDR/IVDR.


Source:

MDCG: Guidance for notified bodies, distributors and importers on certification activities


 

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