Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16 of MDR and IVDR

The Medical Device Coordination Group released a new guidance document regarding the requirements on the quality management system (QMS) to be established by distributors and importers carrying out any of the activities mentioned in points (a)2 and (b)3 of Article 16(2) concerning relabelling and repackaging of devices.

Introduction

Article 16(4) of the MDR / IVDR provides for a notified body to certify that the quality management system of the distributor or importer complies with the requirements laid down in the abovementioned Article 16(3). Notified bodies need to establish the assessment activities necessary in order to certify the quality management system of a distributor or importer intended to relabel and / or repackage a device. This guidance document is mainly focused on activities performed by notified bodies, providing also clarification on the quality management system they are expected to assess. A separate MDCG guidance document, in the form of Questions & Answers, is being developed to complement and address implementation of other relevant requirements for distributors and importers introduced by Article 16 of MDR / IVDR.

The scope of this guidance is to provide assistance to notified bodies with regard to certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer complies with the relevant requirements.

This guidance is also addressed to distributors and importers in respect to their quality management system to be certified by a notified body.

Quality Management System for distributors or importers.

Without prejudice to general obligations that apply to all distributors (Article 14 MDR / IVDR) and importers (Article 13 MDR / IVDR), distributors or importers carrying out any of the activities mentioned in points (a) and (b) of paragraph 2 of Article 16 of the MDR or IVDR are required to ensure that they have in place a quality management system. This quality management system includes procedures, which ensure that the translation of information supplied with the device is accurate and up-to-date. These procedures also ensure that those activities are performed by means and under conditions that preserve the original condition of the device. In addition, they ensure that the packaging of the repackaged device is not defective, of poor quality or untidy. Furthermore, the procedures established under the quality management system should address elements related to contractual relationships to ensure compliance with certain provisions established by Article 16:

• Contracts with any economic operator the distributor or importer is purchasing the device from should ensure that the distributor or importer is informed in a timely manner about any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with the Regulation;
• In addition, the contract between the notified body and the distributor or importer 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, as specified in section 6 of this document.

The quality management system should govern the structure, responsibilities, procedures, processes and management of resources required to implement the principles and actions necessary to achieve compliance with the provisions of Article 16(3) of the MDR / IVDR and is expected to cover and address at least the following:

• documentation of the management system, including responsibility of the management, and development of policies and procedures, Medical Devices Medical Device Coordination Group Document MDCG 2021-23 Page 4 of 7
• resource management, including premises and equipment necessary to carry out activities referred to in points (a) and (b) of Article 16(2) as well as selection and control of suppliers and sub-contractors,
• policies for assignment of activities and responsibilities to personnel ensuring the availability of resources and information necessary to support the operation and monitoring of the activities mentioned,
• procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with the Regulation5 (Article 16 paragraph 2 points (a) and (b)),
• management of corrective actions including procedures for handling non-conforming devices and market recalls due to the activities carried out under point (a) and (b) of Article 16(2), including, when necessary, field safety corrective actions and verification of their effectiveness,
• procedures to ensure traceability of the devices as well as labels, instructions for use and outer packaging indicating the changes made to the product,
• control of documents,
• control of records,
• supervision of the implementation and maintenance of the quality management system, including internal audits and management review.

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