Import of medical devices

We understand an importer of a medical device to be any natural or legal person established in the European Union. It places a product from a third country on the Union market. As the main requirement, it is mandatory to have a prior license as an importer of a medical device, granted by the AEMPS.

PS Consulting has its own license for the import of medical devices. If you are thinking of importing any type of product from a country outside the European Union, contact us and we will carry out the import procedures; while we will manage your own license.

It should be remembered that in addition to the importer’s license, you will have to have at least one person responsible for compliance with the regulations (PRRC) in your company according to the MDR regulation; or a technical manager as stated in Royal Decree 192/2023 of 21 March, which regulates medical devices, a service that we can also offer you.

Whenever a medical device is imported, a number of requirements shall be taken into account to ensure that devices complying with the MDR Regulation 2017/745 are placed on the Union market.

PS Consulting, as an importer of medical devices, will check:

the product is CE marked and the EU declaration of conformity for the product has been drawn up;
the manufacturer is identified and has appointed an authorized representative;
the product is labelled in accordance with the Regulation and accompanied by the necessary instructions for use ;
Where applicable, the manufacturer has assigned the product a unique identifier.

Labelling of the importer of medical devices

The importer shall indicate on the product or its packaging or in a document accompanying the product its name, registered trade name or registered trademark, its registered office and the address at which they can be contacted and which allows them to be located. They shall ensure that the label information provided by the manufacturer is not obscured by other labels.

If you need to import a medical device, call us and we will find the best option that suits your needs.

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