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From the Gov.UK Guidance, "An importer is anybody (individual or business) established in the UK who supplies a product from outside the UK for distribution, consumption or use on the GB market in the course of a commercial activity."
An importer should ensure they know their responsibilities based on the legislation for their product. There should an agreement document between the EU manufacturer and the UK importer listing each entities responsibilities.
In general, here are the UK importer responsibilities:
- "Importers must not place a non-compliant product on the market. They must ensure the manufacturer has carried out the correct conformity assessment procedures, subject to the requirements of the relevant legislation. If the manufacturer has appeared to have supplied non-compliant products, then the importer must take the necessary corrective actions (for example, recalling products from the market) to prevent the products from being placed on the GB market, until they are compliant with the appropriate legislative requirements.
- Where the product presents a risk, the importer must immediately inform the relevant enforcement authority.
- The importer must ensure the manufacturer has drawn up the correct technical documentation in English, affixed conformity markings, and has fulfilled their identification obligations.
- Before placing products on the market, the importer must indicate their details (name, registered trade name or registered trademark, and postal address – usually a number, street, and postcode) on the product. Where this is unwarranted due to the nature of the product, the product specific legislation sometimes permits placing these details on packaging, or placing them on accompanying documentation, as an alternative to placing them to products themselves.
- Importers must ensure that, while the product is under their responsibility, the storage or transport conditions do not jeopardise its compliance with the relevant UK products regulations.
- Importers must retain a copy of the Declaration of Conformity and technical documentation for 10 years after the product has been placed on the market.
- Under certain UK product regulations and depending on which specific regulations apply to you, market surveillance authorities may conduct sample testing of products, if they suspect products are non-compliant."
If needed, the importer (or a distributor) could also act as a UKRP. The UKRP name and address should be included in the device's labeling.
As of now, EU MDR compliant devices, including custom-made devices, can be placed on the GB market up until June 30, 2030 with UKCA Marking.
Original Message:
Sent: 31-May-2023 16:51
From: Anonymous Member
Subject: UK Importer
This message was posted by a user wishing to remain anonymous
Hello fellow RA-professionals,
I am looking for the requirements for UK importer of medical devices. Based on this guidance https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#full-publication-update-history my conclusoin is that the responsibity of a UK Importer is only to notify the UK responsible person that the UK importer is importing a device that the<o:p></o:p>
Our situation is the following, we are a European manufacturer that has been exporting direcly to hospitals in the UK. We have a UK responsible person in place. To facilitate VAT management UK hospitals would prefer to buy from a local UK company. We already have a company set up in the UK for the local sales staff. I'm now evaluating the possibility to use the UK company to import and sell directly to the hospitals i.e. becoming the UK importer. We manufacture custom made devices and the plan is to ship directly from EU to the hospitals with the existing MDR compliant labelling for custom made devices.
Is it then sufficient to notify our UK responsible person of this change to provide the UK importer details to MHRA or are there other requirements the UK importer has to fulfill?
Thanks in advance!