In August 2021, the Medical Device Coordination Group (MDCG) issued guidelines MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16 (4) of Medical Device Regulation (EU) 2017/745 (MDR) and the Regulation on in vitro diagnostic medical devices (EU) 2017/746 (IVDR).

Quality management system for distributors and importers

Article 16 (3) MDR and IVDR provide that distributors and importers of medical devices carrying out the activities referred to in Article 16 (2) (a) and (b) regarding relabelling (including including translation) and repackaging of medical devices should have a quality management system in place to ensure that:

• the translation of information is accurate and up to date;

• the activities carried out do not compromise the original condition of the device; and

• the packaging of the refurbished device is not defective, of poor quality or out of order.

The guide specifies that the procedures included in the QMS must also deal with contractual agreements between the parties concerned. More precisely:

• The contract with any economic operator selling the device and the distributor or importer purchasing the device should include provisions to ensure that the distributor or importer is informed in a timely manner of any corrective action taken by the manufacturer regarding the medical device.

• The contract 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 the importer or their subcontractors if necessary.

In addition, the guide 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 other things, the documentation of the management system, the management of resources, the management of corrective actions and procedures to ensure the traceability of the devices.

A separate question-and-answer session regarding the implementation of related requirements for distributors and importers is under preparation.

Certification of the Quality Management System by notified bodies

The guide details the assessment activities to be carried out by notified bodies to certify the QMS of distributors and importers, in accordance with Article 16 (4) of the RIM and the IVDR.

These activities concern:

• The certification scheme to be established, in accordance with the organization and the general requirements set out in Annex VII of the MDR and IVRD. This scheme concerns the qualification criteria for the selection of the persons involved, the documentation concerning the qualification of the personnel, the conduct of the certification, the changes and modifications, the monitoring activities, the re-certification procedures and the complaints procedures and call.

• The content of the certificates.

• Monitoring, auditing and evaluation of changes, including extensions to the scope of the certificate.