New MDR & IVDR Affects Distributors

We've heard a lot of talk about the changes manufacturers will have to make under the new ED MDR/IVDR. But what about importers and distributors? Their roles are critical to the supply chain process, and it is important that companies understand how they will change as well.

Responsibilities of Importers

An importer is responsible for making sure that the devices they place on the market bear the CE marking, are accompanied by the required information and labelled in accordance with the regulation, and have been assigned a UDI where applicable.

• EUDAMED: Under the new regulations the importer must verify that devices are registered in the European Database on Medical Devices, aka EUDAMED.
• Labelling: On the device, its packaging, or in a document accompanying the device, the importer must make sure their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted is listed.
• Complaints: Importers also have the responsibility to inform manufacturers and their authorized representatives in the event of complaints, and keep the register.
• Authorities: Importers are also required to cooperate with authorities and provide samples or grant access to the devices. They must also inform the authorities if they suspect that a device has been falsified or that there is a serious risk to public health.

Responsibilities of Distributors

A distributor is defined as any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service.

• CE Mark: Distributors should verify that the devices have been CE marked and that an EU Declaration of Conformity has been drawn up.

• Official Language: Distributors must double-check and ensure that product labels and instructions for use are provided in the official languages of the Member States in which the device is made available.
• Documentation: Distributors should also verify that the importer’s name is indicated on each device or in the accompanying documentation, and that the device bears a UDI.
• Storage / Transport: Distributors must make sure that storage and transport conditions, when under their responsibility, are appropriate and in line with the recommendations of the manufacturer.
• Authorities: Distributors should also keep a register of complaints, non-conforming devices, recalls and withdrawals. Distributors shall cooperate with authorities and make available all the documentation and information they have at their disposal.