UK Responsible Person
When is a UK Rep required?
If your company is located outside Great Britain and you want to sell medical or in vitro diagnostic devices (IVDs) in England, Scotland, or Wales, appointing a UK Responsible Person (UK RP/UK Rep) is essential. A UK RP ensures your devices comply with UK regulations and is your liaison with the UK Health Authority and the Medicines & Healthcare Products Regulatory Agency (MHRA).
Since Brexit, medical device companies must meet additional regulatory requirements beyond the EU CE Marking to sell their devices in the UK. The UK RP plays a critical role in helping manufacturers navigate these changes by:
- Registering your devices with the MHRA.
- Ensuring your devices meet UK conformity requirements, including the UKCA marking, will become mandatory from July 2025.
- Acting as the official point of contact between your company and the MHRA for regulatory matters.
After the UK left the EU in early 2020, medical device companies now face additional certification and in-country representation requirements beyond EU CE Marking to market their devices in the UK.
The MHRA published its last update on July 28th, 2023, and intends to introduce legislation to bring into force the transitional arrangements and post-market surveillance activities, as outlined in the government response on June 26th, 2022.
Brexit
Main Impacts for Manufacturers After Brexit
- UKCA Regulation Becomes Mandatory by July 2025
Starting in July 2025, the UK Conformity Assessment (UKCA) marking will be required for all medical devices and IVDs sold in the UK.
Grace Period: Until then, devices with the EU CE mark can still be sold on the UK market under transitional arrangements. - MHRA Registration Required
All medical devices and IVDs sold in the UK must be registered with the Medicines and Healthcare Products Regulatory Agency (MHRA).
Manufacturers must appoint a UK Responsible Person (UK RP) to complete the registration process. - Appoint a UK-Based Entity as UK Responsible Person
Non-UK manufacturers must designate a UK RP as soon as possible.
The UK RP liaises with the MHRA and ensures compliance with UK regulations. - Registration Deadlines by Device Classification
The registration deadlines vary depending on the classification of the device or IVD:
Deadline
Device/IVD class May 1st, 2021 Class IIIs and Class IIbimplantables, all active implantable medical devices; Annex II List A IVDs September 1st, 2021 Class IIb non-implantable, all ClassIIadevices; IVDListB, and Self-test IVDs January 1st, 2022 Class I devices and General IVDs.
- Devices Allowed Under Transitional Arrangements
Until the UKCA marking becomes mandatory in July 2025, manufacturers can sell devices in compliance with the following EU directives and regulations:
Medical Device Directive (MDD)
Medical Device Regulation (MDR)
In Vitro Diagnostic Directive (IVDD)
In Vitro Diagnostic Regulation (IVDR) - Labeling Requirements for UKCA-Marked Devices
The name and address of the UK Responsible Person must appear on the product labeling, outer packaging, or instructions for use if the device bears the UKCA marking.
The UK RP details are not required for CE-marked devices unless the device bears both CE and UKCA markings.
Manufacturers must act promptly to ensure compliance with post-Brexit UK regulations. This includes appointing a UK RP, registering devices with the MHRA, and preparing for the mandatory UKCA marking by July 2025.
