In August 2021, the MDCG issued guidance MDCG 2021-23 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. The document provides guidance to notified bodies regarding the assessment activities necessary to certify the quality management system (QMS) of a distributor or importer relabeling and/or repackaging a medical device. The guidance also provides clarifications to distributors and importers regarding the elements to be included in that quality management system.
In August 2021, the Medical Device Coordination Group (MDCG) issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Medical Devices Regulation (EU) 2017/745 (MDR) and the in vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
Quality Management System for distributors and importers
Article 16(3) of the MDR and IVDR provides that distributors and importers of medical devices that carry out the activities mentioned in Article 16 (2) (a) and (b) concerning relabelling (including translation) and repackaging of medical devices should have in place a QMS to ensure that:
the translation of information is accurate and up-to-date;
the activities performed do not compromise the original condition of the device; and
the packaging of the repackaged device is not defective of poor quality or untidy.
The guidance clarifies that the procedures included in the QMS should also address the contractual agreements between the parties involved. More specifically:
The contract concluded with any economic operator selling the device and the distributor or importer purchasing the device should include provisions ensuring that the distributor or importer is informed timely of any corrective action taken by the manufacturer in relation to the medical device.
The contract concluded between the notified body and the distributor or importer should provide for the possibility of on-site audits at the premises of the distributor and importer or their subcontractors if needed.
Furthermore, the guidance presents a list of elements that the QMS of distributors and importers should cover to comply with the requirements of Article 16 (3) of the MDR and IVDR. These elements concern, among others, the documentation of the management system, the resource management, management of corrective actions and procedures to ensure traceability of the devices.
A separate Q&A regarding the implementation of related requirements for distributors and importers is under preparation.
Certification of the Quality Management System by notified bodies
The guidance elaborates on the assessment activities to be performed by the notified bodies to certify the QMS of distributors and importers, in accordance with Article 16(4) of the MDR and IVDR.
These activities relate to:
The certification scheme to be established, in line with the organisation and general requirement set out in Annex VII of the MDR and IVRD. This scheme concerns the qualification criteria for the selection of the persons involved, documentation regarding the qualification of the personnel, the conduct of the certification, changes and modifications, surveillance activities, re-certification procedures and procedures for complaints and appeals.
The content of the certificates.
The surveillance, auditing and assessment of changes including extensions to scope of the certificate.