New obligations set for importers and distributors under Medical Device Regulation 2017/745

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We have outlined the obligations for importers and distributors in this brief article.

The obligations of all economic operators are now neatly defined and gathered up – the responsibilities for importers can be found in Article 13 and those of distributors in Article 14 of the Medical Device Regulation 2017/745.

The obligations of importers are more extensive than those of distributors. In this context, importer is any natural or legal person established within the Union that places a device from a third country on the Union market and distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, that makes the device available on the EU market.

Both the importer and the distributor are responsible for ensuring that the devices they market bear the CE marking, are accompanied with the required information and labelled in accordance with the Regulation. In addition, the Declaration of Conformity should be available and the devices should bear a UDI, where applicable. Both importers and distributors should make sure that storage and transport conditions defined by the manufacturer are met when the device is under their responsibility, and both have the responsibility to inform manufacturers and their authorised representatives of any complaints or in case there is a reason to believe that the imported or distributed product is not compliant with the Regulation. In addition, both importers and manufacturers should keep a register of complaints, non-conforming devices, recalls and withdrawals, and keep the authorities informed if they suspect that a device has been falsified or that there is a serious risk to health. At the competent authority’s request, importers and distributors must provide samples or access to the devices to the authority.

Importers must indicate their name, registered trade name or trademark, registered place of business and the address at which they can be contacted, on the device, its packaging or in a document accompanying the device. In addition, importers must verify that devices are registered in EUDAMED, the European database on medical devices. It is good to remember that importers should register in EUDAMED while the distributors, when importing or distributing devices in Finland, only register to the Finnish Medicines Agency Fimea. It is also worth noting that even though distributor responsibilities generally apply to all distributors, only operators distributing medical devices to retailers and professional users must register in EUDAMED. For more detailed information, please visit Fimea’s webpage.

If you need assistance in these matters, please contact us!

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