Medical Devices

Brexit and EU Flag Post outside Big Ben

Ensuring compliance for UK market entry for Medical Devices

What is a UK Responsible Person (UKRP) for Medical Devices?

A UK Responsible Person (UKRP) for medical devices is a person or company established in the United Kingdom who acts on behalf of an overseas manufacturer, to ensure that their medical devices comply with UK regulations. This role became essential after Brexit.

Why do you need a UKRP?

Placing medical devices on the UK market requires full compliance with national regulations. For manufacturers outside the UK, appointing a UK Responsible Person (UKRP) is a legal requirement under the UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended).

Our Service

At UKRepMed, we provide expert UKRP services to ensure your devices meet all UK regulatory obligations and are registered to be sold confidently in the UK. This includes:

1. Legal Compliance

We ensure your device:

  • Meets relevant conformity assessment procedures
  • Has a valid Declaration of Conformity (DoC)
  • Bears the correct UKCA or CE mark (where permitted)
  • Has full technical documentation available for MHRA inspection.

2. Device Registration

We register your devices with the MHRA via the Device Online Registration System (DORS), ensuring full compliance before market entry.

3. Labelling

We provide full contact details for your product labelling, ensuring a clear contact point for authorities and end users.

4. Safety and Vigilance

We maintain the highest safety and vigilance including:

  • Reporting safety concerns, complaints and incidents to you
  • Liaising with the MHRA on corrective actions to manage notices and minimise risk to protect patients and your brand
  • Supporting post-market surveillance (per Regulation 7A(4)).

5. Ongoing Regulatory Support

We monitor the market to stay abreast of regulatory changes, providing continuous support to ensure your devices remain compliant throughout their lifecycle.

Set-up in five easy steps

We work quickly to review your products, to ensure your cosmetics comply with UK regulations and reach the market smoothly. Our hassle-free process can be completed in five easy steps:

1. Assessment

We evaluate your products and business to determine to the scope of responsibilities required.

2. Feedback

If your documents are in order, we proceed. If not, we guide you on closing gaps.

3. Quote and Contract

We quote for our UKRP service and send the service agreement for signature.

4. Set up

We create your file for registration and review labels.

5. Completion

Once set-up is complete and labels are compliant, your products can be placed on the UK market.

Why Choose UKRepMed?

  • Expertise: Our team has extensive experience in UK Medical Devices Regulations and stays updated on any legislative changes.
  • Dedicated Support: We offer personalised assistance tailored to your specific products and business needs.
  • Efficiency: We ensure timely compliance, helping you avoid market entry delays.
  • Transparency: We provide clear communication and detailed documentation at every step.
  • Ongoing service: We offer ongoing support so you can rest assured your products are in good hands and will remain compliant.

Get Started with UKRepMed

We pride ourselves on being competitively priced. Costs for our UKRP service for Medical Devices vary depending on the nature of your product, regulatory needs and business size. Contact us today for a personalised quote and take the first step towards selling your products in the UK.

Name