The Importance of Appointing a Single UK Responsible Person (UKRP) for the GB Medical Device Market

As the UK regulatory landscape continues to evolve post-Brexit, one of the key obligations for overseas medical device manufacturers wishing to market their products in Great Britain is the appointment of a (single) UK Responsible Person (UKRP). This role is central to compliance, communication, and accountability within the UK medical device framework.

Why appoint just one UKRP?

UK regulations require that each non-UK manufacturer appoints a single UK Responsible Person per manufacturer, not per product line or device. This requirement brings consistency, traceability, and clarity to regulatory oversight.

The MHRA guidance Regulating medical devices in the UK states the following about this requirement:

“If you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK responsible person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration”

Having multiple UKRPs for the same manufacturer could lead to conflicting submissions, disconnected communication channels, and regulatory confusion. A single UKRP ensures that:

• Communication with the MHRA is streamlined and efficient.
• Accountability for compliance tasks is clear and consistent.
• The manufacturer’s product portfolio is managed under a unified regulatory strategy.

Essentially, one UKRP acts as the single point of contact and control, reducing risk and administrative burden for both the manufacturer and the regulator.

Is it possible to transfer to another UKRP?

While you can only appoint one UKRP at any given time, you may decide to transfer representation from one UKRP to another. This transfer must be handled carefully and timing is essential to prevent gaps in regulatory responsibility that could delay in product availability.

The typical transfer process involves:

1. Approach the new UKRP and notify the outgoing UKRP of the request to unregister.
2. The outgoing UKRP must unregister the MHRA registration. They should do so by selecting that they no longer represent the manufacturer as the UKRP. This process takes only a few minutes. The MHRA will then send an email notification out to both the UKRP and the manufacturer confirming the de-registration. At this point the manufacturer cannot lawfully place devices on the GB market until the new UKRP registers a new account with the MHRA again.
3. Alignment and good communication regarding timelines with the newly appointed UKRP is key! The manufacturer will provide the newly appointed UKRP with all relevant documentation and the new UKRP will submit a new registration application to the MHRA.
4. The MHRA will review the application (this usually takes 3-5 business days) and will provide the UKRP with a confirmation letter once approved, which will be shared with the manufacturer.

Once the registration is completed, the MHRA will publish the manufacturer and device registration on their public database (PARD), including the details of the new UKRP.

Labelling Compliance During a UKRP Transfer

Medical devices placed on the Great Britain market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under. Where relevant, the number of the approved body or notified body must also appear on the label.

Devices can have both the CE and UKCA markings present on the labelling. However, the name and address of the UK responsible person, where applicable, needs to be included on product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked).

Manufacturers are legally required to notify the MHRA of changes to their registration (including changes of UKRP) “as and when they occur” under the UK MDR 2002 and MHRA Guidance.

The MHRA has not published any statutory “sell-through” or grace periods for relabelling when a UKRP is transferred. Therefore aim to update labels/packaging/IFU as soon as reasonably practicable once the new UKRP is registered.

What this means for already-manufactured stock:

• If stock already placed on the Great Britain market under the old UKRP was compliant at the time of placing on the market, it is not usually retrospectively unlawful to sell it. However, because the UKRP must be the contact point for compliance, it is best practice to:

(a) ensure the new UKRP has the product technical file and can support post-market duties; and

(b) add the new UKRP details on the product labelling or the outer packaging or the IFU before further distribution.

Practical advice for the manufacturers:

1. Notify the old UKRP to de-register your account in the MHRA database.
2. Ensure the new UKRP has been properly appointed and registered the devices with the MHRA.
3. Update your Declaration(s) of Conformity and technical documentation to indicate the new UKRP, when in compliance with UK MDR 2002.
4. When in compliance with UK MDR 2002, update IFU / outer packaging immediately where feasible and plan label artwork change for next production run.
5. Keep records (dates of MHRA notification, stock levels, actions taken) in case of queries during market surveillance.

Would you like to have more information on the process of transferring over from one UKRP to another? Or about what documentation is required during transfer for your devices? Qserve’s Global Registration Team can help you with a smooth and fast transition. Contact us today!