The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for regulations in the sphere of medical devices, has published guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic medical devices Regulation 2017/746 (IVDR).
The MDCG emphasizes that the present document should not be construed as officially issued by the European Commission, and all the provisions thereof are non-binding in their nature. The document is intended solely to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be followed by the parties involved in operations with medical devices in order to achieve and sustain compliance with the provisions of the current legislation.
According to the provisions of the aforementioned Regulations, distributors and importers of medical devices should duly implement the appropriate quality management system addressing the matters related to relabelling and repackaging medical devices. Moreover, a notified body duly designated under the Regulations will be entitled to certify that the quality management system of the distributor or importer complies with the requirements laid down in the Article 16(3) of the MDR/IVDR. The MDCG additionally emphasizes that in order for a notified body to be eligible for such an activity, the scope of its designation should cover the particular types of medical devices involved. At the same time, it is important to mention that such certification activities to be performed by [notified bodies] are not related to conformity assessment activities carried out to certify manufacturer’s device according to either Article 52 of the MDR or Article 48 of the IVDR. The present MDCG guidance is intended to provide additional clarifications with regard to the particular aspects to be taken into consideration in the context of quality management systems to be established and implemented by medical device distributors and importers. In particular, the document describes the scope of assessment and outlines the points requiring the most attention. The MDCG states that other aspects related to the obligations of medical device distributors and importers would be agreed upon in separate guidance documents that would be issued later.
The scope of the present MDCG guidance covers the assessment to be performed by notified bodies with regard to the quality management system implemented by a distributor or importer in order to verify its compliance with the applicable regulatory requirements. The document also provides the appropriate recommendations to be followed by medical device distributors and importers.
QMS for Distributors and Importers
As mentioned, the new Regulations prescribe that medical device distributors and importers are obliged to establish and implement the appropriate quality management system (QMS). According to the guidance, this quality management system includes procedures, which ensure that the translation of information supplied with the device is accurate and up-to-date. The MDCG also mentions that the activities performed by distributors and importers before making the device available on the EU market should not impact its safety and performance. In general, the regulations require the packaging of a medical device subject to repackaging before being placed on the market to comply with the requirements describing its quality.
As stated by the MDCG, the scope of procedures to be introduced by medical device distributors or importers as described herein should cover the following aspects:
- Ensuring that the distributor or importer would be notified without undue delay about any changes to the medical device in question, including but not limited to modifications introduced by the medical device manufacturer, as well as corrective and preventive actions initiated by the manufacturer in order to mitigate the risks associated with the device already placed on the market;
- Notified bodies should be allowed to carry out on-site inspections of medical device importers and distributors in order to assess their compliance with the applicable regulatory requirements.
The MDCG also mentions that procedures being part of the quality management system should ensure that the activities according to Article 16 paragraph 2 points (a) and (b) performed by the distributor or the importer do not affect compliance of the device with the applicable requirements. According to the present guidance, the QMS the abovementioned parties are obliged to develop and implement should describe the particular way the entity will fulfill the applicable regulatory requirements set forth under the new Regulations. It is further stated that the scope of the quality management system should cover the following aspects:
- Description of responsibilities of the company’s management, including details about the respective policies and procedures;
- Utilization of equipment and premises required, as well as the policy regarding the subcontractors;
- Policies regarding the information to be obtained;
- Policies regarding the personnel involved in activities carried out by a medical device distributor or manufacturer;
- Description of procedures implemented in order to ensure all the parties involved in operations with a medical device would be duly informed of any corrective action taken by its manufacturer;
- Information about the particular way such corrective actions would be managed;
- Description of the measures taken in order to ensure traceability of the product in question;
- Control of documents;
- Control of records;
- Supervision of the implementation and maintenance of the quality management system, including internal audits and management reviews.
Thus, a quality management system to be developed and implemented by the medical device distributor or importer should at all times be compliant with the respective regulatory requirements set forth by the MDR and IVDR.
As mentioned, in order to be eligible for conducting the QMS certification as described herein, a notified body should be duly designated to conduct a conformity assessment of the appropriate type of medical devices. Additionally, a notified body should have personnel having the necessary knowledge and qualification to conduct such an assessment. The new Regulations also prescribe the requirements in terms of documenting all the actions performed, as well as record-keeping. The procedures describing the certification activities carried out by notified bodies should also be duly documented and cover such aspects as performing on-site and off-site inspections, reporting, and decision-making processes.
In summary, the present guidance document published by the MDCG addresses the most important aspects to be taken into consideration with regard to the quality management systems to be developed and implemented by medical device importers and distributors. The guidance outlines the responsibilities of the parties involved and provides additional clarifications regarding the applicable regulatory requirements.
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