UK Responsible Person for Medical Devices

Many medical device manufacturers wonder whether information on the UK Responsible Person and UK Importer must be displayed on the product label, instructions for use, or packaging when selling their products in the UK.

This directly affects whether the product will face market surveillance investigations or be removed from sales platforms.

Printing Requirements for UK Responsible Person & UK Importer Information

UK Responsible Person Information

If you are a medical device manufacturer based outside the UK, you are required to appoint a UK Responsible Person (UK RP).

For products placed on the UK market via the UKCA (UK Conformity Assessed) route, the name and address of the UK RP must appear on the product label, outer packaging, or instructions for use.

There is currently no unified logo for UK RP; you may refer to the following examples to present the information:

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or

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For products placed on the UK market via the ce conformity Assessment route, UK RP information does not need to be displayed, and standard ce labelling may be used directly.

Important Note:

Regardless of the route used to access the UK market, the UK Responsible Person must submit registration with the MHRA.

UK Importer Information

UK Importer information is not required to appear on product labels.

However, in accordance with regulatory requirements, the UK RP or manufacturer must submit full UK Importer details to the MHRA.

To ensure your products can enter the UK market in full compliance, we recommend:

1. Clearly display UK RP information

Manufacturers placing products on the UK market via the UKCA route must ensure the appointed UK RP’s name and address are clearly and accurately marked on the product label, outer packaging, or instructions for use.