The EUROPEAN REGULATION 2017/745 (MDR) will formally introduce the role of the “importer” defined as any natural or legal person established within the Union that places a device from a third country on the Union market.
The obligations of the importers have been defined in article 13 of the MDR.
According to article 13, importers, before placing the device on the market, have the responsibility to verify that:
- the device has been CE marked,
- that the declaration of conformity of the device has been drawn up (they have also the duty to keep a copy of the EU declaration of conformity)
- that the manufacturer/authorized representative is identified. Importers shall also verify that the labelling of the device is compliant to the requirements of the MDR (including the UDI requirements when they will be applicable).
Additionally, importers shall indicate on the device, on its package or in a supporting document their name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted, so that their location can be established. This aspect is crucial, considering also that the additional label must not obscure any information on the label provided by the manufacturer.
As concerns storage and distribution, importers must assure under their responsibility that the storage and distribution conditions set for the device are respected. Importers are also required to have an adequate system to manage complaints and reports of suspected incidents and to promptly communicate them to the legal manufacturer. Importers should keep a register of complaints, of non-conforming devices and of recalls and withdrawals, as well.
Regulatory Pharma Net offers regulatory support to Medical Devices companies to be compliant with the requirements of the new MDR 2017/745. We are available for any clarification, do not hesitate to contact us!