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.
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