Obligations for importers are defined in Article 13 of the MDR. They concern both product compliance in the strict sense of the word and interactions between importers and other economic operators, such as manufacturers, their authorized representatives and relevant supervisory authorities. Where a device poses an unreasonable risk to the end consumer, importers and distributors should inform the relevant Member State and the notified body without delay. Do you have an EU MDR compliance plan? NAMSA`s global regulatory experts welcome the opportunity to discuss strategic options for the new EU MDR rules, including the potential commercial implications for medical device distributors and importers in the EU. How can you plan for success? Contact us at [email protected] or visit our regulatory advice website to find out how we can help countless medical device organisations succeed under the EU`s latest regulatory landscape. In addition, importers and distributors should immediately forward complaints or reports from end-users to the manufacturer or agent regarding alleged incidents involving the device concerned. Finally, it should be stressed that distribution and supply agreements provide only for formal compliance with the rules. In practice, economic operators must examine how relevant information can be shared and managed to comply with legislation, so that actions taken by a particular economic operator do not compromise the interests or respect of other partners upstream or downstream. After the MDR comes into force, importers are subject to a large number of new legal obligations.

In some cases, they may even act as manufacturers. Importers need to be aware of this in order to take the necessary steps to properly meet these obligations. If importers do not do so, they may face significant liability risks in the future because they do not comply with the MDR. When is a device “under the responsibility” of the distributor or importer? In the case of contractual liability, distributors and importers have a strong incentive to limit the duration of liability of a device or to try to remove liability as much as possible.