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Q&A document published on requirements under Articles 13 and 14 of MDR and IVDR

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Published on: 13 December 2021

Published by LNB News

LNB News 13/12/2021

Document Information

Issue Date: 13 December 2021

Published Date: 13 December 2021

Jurisdiction(s): European Union

Article summary

The Medical Device Coordination Group (MDCG) has published a Q&A document regarding the requirements and obligations for importers and distributors under Articles 13 and 14 of Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)). It covers questions such as which economic operators meet the definition of importer or distributor, how it is determined whether a natural or legal person is able to act as a distributor or an importer, whether there can be multiple importers of a device model from one manufacturer, if individual shops, community pharmacies, retailers or other persons can be considered distributors, and what the obligations of importers and distributors are with respect to suspected non-compliant products.

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