The Medical Device Coordination Group (MDCG) issued Guidance 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. It relates to cases when obligations of manufacturers apply to importers, distributors or other persons.
This guidance focuses on the activities that should be carried out by both notified bodies and distributors/importers within the certification procedure of the quality management system according to requirements established by MDR and IVDR.
First of all, distributors/importers are required to ensure that they have a relevant quality management system. They are responsible for providing translation of the information supplied by the manufacturer such as label and instructions for the use and changing the outer packaging of a device already placed on the market as well as its relabelling.
The MDCG pays attention to the provisions of the contracts between the economic operator and distributor/importer and notified body and distributor/importer. The first one should contain the provision on the timely informing one party about any changes regarding safety issues. The other should specify the possibility for the notified body to perform on-site audits at the premises of the distributor and importer or their subcontractors if needed. Initial certification of the distributor/importer’s quality management system should always include on-site audit.
Additionally, to on-site audits, there are annual surveillance audits that allow to check if the QMS operates properly or not. However, the notified body should perform one surveillance audit between 12 and max 24 months after the first certification.
At the end of each certification cycle (3 years), a re-certification audit should be conducted in order to renew the certificate and requires on-site recertification audit.
Please note, if there are some non-conformities during the audits, additional audits may be conducted, either onsite or off-site.
More detailed information you can find in the guidance here.
The information has been prepared by the GMA Consult Group team.
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