MDCG offers new guidance on clinical investigations, importers and distributors

Regulatory NewsRegulatory News | 09 December 2021 |  By 

The European Commission’s Medical Devices Coordination Group (MDCG) on Thursday issued 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 modification to a clinical investigation, to be used as a stopgap before the Eudamed electronic reporting system is fully functional.
Importers and distributors
In its 11-page questions and answers guidance on Articles 13 and 14 of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), MDCG discusses the roles and responsibilities of importers and distributers under the two regulations.
The guidance offers insight on distinguishing between the two roles and general obligations under the regulations. Also addressed are specific obligations for verifying that products are CE marked and are in compliance with registration and other requirements. The guidance also offers several practical examples of different situations involving the import or distribution of medical devices and IVDs.
The distinction between an importer and distributor, the guidance explains, hinges on whether the economic operator places a device on the market that it obtained from an economic operator in a third country or whether the economic operator obtained the device from another manufacturer, importer or distributor that is established in the European Union. The guidance notes that EU-based distributors become importers if they obtain products directly from a non-EU based manufacturer or distributor.
The guidance also offers some information on the obligations of importers for including their own information on a device, its packaging, or accompanying documentation and provides information on handling devices that have been exported and reimported to the EU.
In most cases, the guidance explains, third party logistics providers, such as transportation and storage companies, are not considered importers or distributors, as they typically do not have legal ownership of the products.
Other issues discussed in the guidance include the handling of suspected non-compliant products, complaint reporting, and the application of MDR/IVDR obligations to legacy devices. Additionally, the guidance touches upon product verification and registration responsibilities for importers and distributors, as well as device traceability.
Substantial modification of clinical investigation
Under MDR, sponsors of clinical investigations are required to notify the relevant member states if they intend to modify the investigation in a manner that would have a “substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, within one week.”
However, as Eudamed, the electronic system referred to in Article 73 of MDR, is not fully functional, MDCG has created a series of documents for clinical investigation applications and notifications to support the required submissions until Eudamed is ready.
In the brief guidance on substantial modifications, MDCG links to a template for submitting such notifications, though it explains that competent authorities and sponsors should check with the individual member state(s) about specific national requirements before using the template. MDCG adds that it intends to withdraw the template once the Eudamed clinical investigations module is functional.
Substantial modification of clinical investigation under Medical Device Regulation
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746


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