UK MARKET ACCESS FOR MEDICAL DEVICES AND IVDs
Need to place a medical device or IVD on the UK market?
Select IMed Consultancy for UKRP services and benefit from fast and easy UK registration or transfer for your Medical Devices (MDs) & In Vitro Diagnostics (IVDs)
HOW TO PLACE AND MAINTAIN A DEVICE ON THE UK MARKET
After Brexit, the UK is no longer part of the EU so European Medical Device Regulation is no longer applicable. UK-specific regulation on the other hand, is still in flux.
Despite this, the UK remains a commercially attractive market for your medical devices and IVDs, provided that you meet the following requirements for ex-UK manufacturers:
- Demonstrate compliance with UK MDR 2002
- Devices can be CE-marked or UKCA-marked
- Appoint a qualified UK-based UKRP like IMed Consultancy
- IMed will act on your behalf and register with the MHRA
In addition, IMed Consultancy will keep you updated with the latest regulatory intelligence. Protect your position with a qualified, expert UKRP.
ARE YOU LOOKING FOR A UKRP LIKE IMED CONSULTANCY?
IMed Consultancy for UK market access
Working with IMed consultancy provides you with direct access to a permanent team of UK-based QA/RA experts that can guide you in entering the UK market.
With experience supporting medical device and IVD manufacturers with their regulatory and compliance requirements globally, IMed Consultancy is ready to support your business here in the UK.
UK REGULATORY INTELLIGENCE FOR MEDICAL DEVICES AND IVDs
We’ve got you covered! Visit our website for strategic guidance on UKRP and other regulatory issues.
Meeting UK regulatory requirements
IMed Consultancy is much more than just a UKRP post-box service.
Our team of highly skilled and experienced medical device regulatory professionals can support your company in meeting all your UK market regulatory requirements.
Our expert consultants understand the commercial world of placing and maintaining devices on the market and can guide you, advise you and make sure you avoid the regulatory minefields.
We make compliance simple and efficient so that you can provide safe and effective medical devices.
What our Clients Say
“I want to thank Jade and other team members from IMED for their various and great support all along to our company, including MHRA registration, UK regulatory consultation, etc.
All team members always have a friendly attitude, be good at communicating, work proactively and efficiently during the past years, which provided great help for the registration and marketing of our products in UK”
GRI Medical & Electronic Technology Co. Ltd (China)
UKRP Frequently Asked Questions (FAQ)
Why do I need a UKRP?
Manufacturers based outside the UK are required to appoint a UKRP to place a device on the UK market (England, Wales and Scotland). If you are a non-UK manufacturer placing a IVD on the Northern Ireland market, you may be required to appoint a single UKRP. Non-UK manufacturers are not required to appoint a UK Responsible Person for the purpose of placing other devices on the Northern Ireland market.
What does a UKRP do?
All devices placed on the UK market must be registered with the MHRA before they can be placed on the market. Non-UK manufacturers must appoint a UK resident UKRP to register their device(s) on their behalf. The UKRP then acts on behalf of the ex-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations as outlined by MHRA guidance.
Can I appoint more than one UKRP?
Does my device need to be UKCA marked?
Do the UKRP details need to be included on the device?
Only in cases where the device has been UKCA marked or is dual marked (UKCA + CE). Where UKRP details are required, the name and address of the UKRP should be included on product labelling or the outer packaging, or the instructions for use.
When do the UK Devices Regulations Change and what does this mean?
In 2023, the UK government has clarified that it intends to extend the UK Regulations to better align with international best practice. They are expected to be released in three new statutory instruments in 2023.
Can my importer also be my UKRP?
Yes. There is nothing to prevent an importer or distributor from also acting as a UKRP. The responsibilities of the UKRP do still require an in depth understanding of the regulatory requirements for medical devices, so you should appoint your UKRP carefully. You may wish to consider a separation in regulatory and commercial interests.