Any individual or company intending to import a medical device into Great Britain must first;
- be established (ie. resident or registered) in Great Britain,
- and, if they are not the UK Responsible Person appointed by the non-UK manufacturer, inform the relevant UK Responsible Person of their intention to import the device.
The UK medical device regulations require the details of all importers of medical devices into Great Britian to be registered with MHRA. That registration can only be made by the sole appointed UK Responsible Person. Similar rules apply in Northern Ireland.
It would be an offence, under the UK regulations, to place a medical device on the market that does not meet the UK’s requirements. It is advisable therefore, for anyone intending to import medical devices into the UK, to be familiar with the regulations that apply and to first verify the device concerned is compliant.
The general rules for importers of goods into the UK also apply to importers of medical devices. Those rules can be viewed by clicking the button below.
What are the pre-requisites to become an UK Importer? What are the Importer requirements in terms of QMS, licensing, dedicated resources, Infrastructure, maintenance, insurance etc?
There are no qualification requirements for importers in the current version of the UK MDR. The only requirement is to inform the UK Responsible Person of your intention to import the device. That said, all UK importers have general obligations, including obligations to check the labelling and applicable marketing rules; but these obligations are not exclusive to importers of medical devices.
Consult the following pages:
https://www.gov.uk/import-goods-into-uk
https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-great-britain