A frame is a medical device in Britain

In Great Britain, a spectacle frame is classified as a Class I medical device.

A manufacturer established outside the United Kingdom cannot place a medical device on the British market until it appoints a UK Responsible Person. This has been the law since January 2021.

The UK Responsible Person registers the manufacturer and its devices with the Medicines and Healthcare products Regulatory Agency. They hold the technical documentation, handle reporting obligations, and act as the manufacturer's point of contact with the regulator in Britain.

A manufacturer may appoint only one UK Responsible Person, and the appointment is exclusive.

Many workshops in Fukui have never appointed one. Until they do, their frames cannot lawfully be sold in Britain.

This is the work we do.

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UK Responsible Person

We act as your UK Responsible Person under the UK Medical Devices Regulations. We verify your Declaration of Conformity and technical documentation, register you and your frames with the MHRA, handle vigilance reporting and post-market surveillance, and deal with the regulator on your behalf.

Importer of record

We take title to the goods at the British border. We handle customs declarations, commodity classification, duty and import VAT. You issue one invoice, to one British company. Your obligation ends at export.

The MHRA registration fee is approximately £300 per year, per device category. Your whole frame range sits in one category, however many models it contains. Our fee is [£X per year]. Specialist compliance firms in Britain charge several thousand pounds per year for the same role.

Agency

We represent your line to British opticians. We make the visits, carry the samples, open the accounts and manage reorders.

You keep ownership of your stock. We are paid a commission on what we sell. You gain a presence in Britain without establishing a British company.

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