Everything you need to know about UK Responsible Person (UKRP) for Medical Devices
Introduction
If you’re a medical device manufacturer based outside the UK and want to sell your products in Great Britain (England, Scotland, and Wales), you’ve probably come across the term “UK Responsible Person” (UKRP). But what does it mean, and why do you need one?
In this post, we’ll break down the role of a UKRP, why it’s essential for compliance, and what to look for when choosing the right one for your business.
Why Do You Need a UK Responsible Person?
Since Brexit, the UK now has its own set of medical device regulations separate from the EU. If your business isn’t based in the UK, you’ll need a UKRP to act as your representative to meet these new rules. Essentially, the UKRP ensures your devices comply with UK regulations and helps you get them approved for sale in Great Britain.
Think of the UKRP as your bridge to the UK market—they handle the legal and regulatory side so you can focus on running your business.
What Does a UKRP Actually Do?
Here are the main responsibilities of a UK Responsible Person:
Registering Your Devices
The UKRP registers your devices with the MHRA (the UK regulator) before they’re allowed on the market. Without this step, your products can’t be sold in the UK.Checking Your Documentation
They’ll make sure your paperwork is in order, including:Your Declaration of Conformity (proving your device meets UK standards). We provide an outline of this here - https://www.theotherconsultants.com/blog/declaration-of-conformity-template-uk-and-eu
Your Technical File (detailed documentation about your device).
Ensuring your product carries the UKCA mark.
Handling Post-Market Issues
If something goes wrong with your device after it’s on the market, the UKRP is the go-to contact for the MHRA. They’re responsible for reporting serious incidents and managing any safety updates or recalls.Liaising with the MHRA
The UKRP communicates directly with the MHRA on your behalf. Whether it’s a question about your device or responding to regulatory updates, they’ve got you covered.Keeping Records Safe
They’ll keep a copy of your technical documentation on file, ready for inspection if the MHRA needs it.
How Do You Appoint a UKRP?
To appoint a UKRP, you’ll need to sign an agreement that gives them the authority to represent you. It’s important to spell out exactly what they’re responsible for so everyone’s on the same page.
What Should You Look for in a UKRP?
Choosing the right UKRP is a big decision. Here are some tips to help you find the best fit:
Expertise: Look for someone who knows the ins and outs of UK medical device regulations.
Responsiveness: They should be quick to handle issues like safety reports or regulatory changes.
Data Security: Make sure they can protect your sensitive technical information.
Proven Track Record: A good UKRP should have experience and a solid reputation in the industry.
Why the UKRP Role is Critical
A UK Responsible Person isn’t just a regulatory checkbox—they’re your partner in navigating the complexities of the UK medical device market. From getting your devices registered to managing post-market compliance, the UKRP helps ensure your business stays on track and your products stay on the shelves.
How We Can Help
At The Other Consultants, I know how challenging regulatory compliance can be—especially in a post-Brexit world. That’s why I can act as your dedicated UK Responsible Person and make things easier for you.
Whether it’s registering your devices, handling documentation, or liaising with the MHRA, I’ve got the expertise and experience to keep you compliant and confident. Let me take the stress out of UK market access so you can focus on what you do best: innovating and growing your business.
Get in touch today to learn more about our UKRP services and how I can help you succeed in the UK market.