Regulating Medical Devices in the UK
Regulating Medical Devices in the UK (UKRP) – Medical Devices
AMI Ltd is registered with the MHRA and acts as a UK Responsible Person (UKRP) for overseas manufacturers.
We ensure your products meet UK MHRA compliance requirements so you can legally sell your medical devices in the UK — without setting up a UK office or holding stock locally.
Our service includes:
- MHRA registration for your products
- Ongoing compliance monitoring to meet UK MDR 2002 (as amended)
- Direct liaison with UK regulators – so you don’t need a local office
- Market entry support – connecting your products to NHS Supply Chain and private healthcare networks
UK Responsible Person (UKRP)–Medical Devices
The role of the UKRP was introduced when the United Kingdom left the European Union and became a “third country.”
This change meant that the UK no longer follows new EU legislation such as the Medical Device Regulation (MDR) EU 2017/745 and In Vitro Diagnostic Regulation (IVDR) EU 2017/746.
Instead, the UK follows the UK Medical Device Regulations 2002 (as amended), which are based on the previous EU Medical Device Directives. These regulations were updated post-Brexit to remove EU-specific provisions and introduce a UK equivalent to the EU Authorised Representative — the UK Responsible Person.
What is a UKRP?
If you are a manufacturer without a registered business in the UK but wish to place medical devices or in vitro diagnostics (IVDs) on the UK market, you must appoint a UK Responsible Person.
The UKRP:
- Represents you in the UK.
- Registers your medical devices and IVDs with the Medicines & Healthcare products Regulatory Agency (MHRA).
- Ensures ongoing compliance with UK MDR 2002.
This applies to all manufacturers, including:
- Class I medical device manufacturers who self-certify.
- Self-certified IVD manufacturers.
EU-based manufacturers selling into the UK.
What Does the UKRP Do?
A UKRP acts on behalf of the non-UK manufacturer to carry out specific tasks, including:
- Ensuring the Declaration of Conformity and technical documentation have been drawn up and the correct conformity assessment procedure has been carried out.
- Keeping copies of technical documentation, Declaration of Conformity, and relevant certificates (including amendments) for MHRA inspection.
- Providing the MHRA with all documentation required to demonstrate device conformity.
- Facilitating MHRA requests for samples or access to the device.
- Cooperating with MHRA on preventive or corrective actions.
- Immediately informing the manufacturer of complaints and incident reports from healthcare professionals, patients, or users.
- Terminating the legal relationship with the manufacturer and informing MHRA if the manufacturer fails to meet their obligations.
Do You Need a UKRP?
You must have a UK Responsible Person if:
- You are a Medical Device and/or IVD Manufacturer without a registered business in the UK.
- You are based in the EU or outside the UK and wish to sell into the UK market.
Why Choose AMI Ltd as Your UKRP?
- Registered UK company with healthcare procurement expertise.
- Established relationships with NHS procurement teams for faster market penetration.
- No stock-holding requirement – products can ship directly to UK customers.
- Proven experience helping global Medical Device and IVD manufacturers achieve UK compliance.
Contact Us
If you need a UK Responsible Person for your medical devices or IVDs, AMI Ltd can represent you and manage the entire compliance process.
📩 Email: sales@aayanmedical.co.uk