MDCG Offers New Directions on Clinical Investigations, Importers and Distributors
Posted on December 09, 2021 | Through
The European Commission’s Medical Device Coordination Group (MDCG) on Thursday released new guidance documents offering questions and answers on the import and distribution of medical devices. The group also provided sponsors with a template for notifying Member States of a substantial change in a clinical investigation, to be used as a stopgap before the Eudamed electronic notification system is fully functional.
Importers and distributors
In its 11-page Q&A on Articles 13 and 14 of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulation, the MDCG examines the roles and responsibilities of importers and distributors under both regulations.
The guidelines provide an overview of the distinction between the two roles and the general obligations under the regulations. Also discussed are specific obligations to verify that products are CE marked and comply with registration and other requirements. The guide also offers several practical examples of different situations involving the importation or distribution of medical devices and IVDs.
The distinction between an importer and a distributor, explains the guide, depends on whether the economic operator places on the market a device that he has obtained from an economic operator in a third country or whether the economic operator has obtained the device from another manufacturer, importer or distributor who is established in the European Union. The guide notes that EU-based distributors become importers if they obtain products directly from a non-EU-based manufacturer or distributor.
The guide also offers information on the obligations of importers to include their own information on a device, its packaging or accompanying documentation and provides information on the handling of devices that have been exported and re-imported to the EU.
In most cases, the guide explains, third-party logistics providers, such as transport and storage companies, are not considered importers or distributors, as they generally do not have legal ownership of the products.
Other issues addressed in the guide include dealing with suspected non-conforming products, reporting complaints, and applying MDR / IVDR obligations to existing devices. In addition, the guidelines address product verification and registration responsibilities for importers and distributors, as well as device traceability.
Substantial modification of the clinical investigation
Under the MDR, sponsors of clinical investigations are required to inform the Member States concerned if they intend to modify the investigation in a way that would have a “substantial impact on safety, health or the rights of the subjects or the robustness or reliability of the clinical data generated by the survey, within one week.
However, as Eudamed, the electronic system referred to in Article 73 of the MDR, is not fully functional, the MDCG has created a series of documents for clinical investigation requests and notifications to support the required submissions until that Eudamed is ready.
In the brief guidelines on substantial changes, the MDCG refers to a template for submitting such notifications, although it explains that competent authorities and sponsors should check with each member state for specific national requirements before using the template. . The MDCG adds that it intends to withdraw the model once the Eudamed clinical investigations module is operational.
Substantial modification of the clinical investigation under the Medical Devices Regulation
Questions and answers on Articles 13 and 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
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