IMed launches new UKRP resource to inform businesses after surge in demand for UKRP services
IMed Consultancy, a rising regulatory and compliance consultancy provider has launched a new UKRP-focused website to shed light on the role of the UK Responsible Person. With extensive experience supporting UK and international medical device and in vitro diagnostic medical device manufacturers, the company identified a need to help educate the manufacturing industry, and specifically businesses wanting to launch or keep a medical device on the UK market, on the role of the UKRP. Visit the website here.
The requirements for businesses wanting to enter the market in Great Britain are as follows as of January 2021:
- Registering with the MHRA
- Appointing a single UK Responsible Person (UKRP) for all of their devices. This person will act on their behalf to carry out specified tasks, such as registration
- Compliance with relevant product marking and conformity assessment requirements for medical devices
A UK Responsible Person, or UKRP, is a requirement for ensuring a medical device can be placed and maintained on the UK market. The UKRP acts on behalf of businesses based outside the UK to carry out all tasks needed to successfully place their device on the UK market and liaise with entities such as the MHRA. UKRPs are also responsible for ensuring the declaration on conformity and all technical documentation have been drawn up, keeping available a copy of all relevant documentation and immediately informing manufacturers about complaints and reports from healthcare professionals, patients and users.
After seeing a surge in demand for UKRP services, IMed decided to set up a dedicated website, reviewed and developed by the Consultancy’s team of experienced UK regulatory professionals, to resolve UKRP related concerns and questions. IMed’s UKRP website will not only guarantee a fast-track access to IMed’s UKRP services, but will also give companies access to free resources and answers to common concerns via the FAQ section.
“We’re fully aware of the difficulties foreign companies are facing when deciding to place a medical device or IVD on the UK market, especially with changing requirements and the MHRA continuously updating guidance,” explains Matthew Burton, Strategic Development Director at IMed Consultancy. “Choosing the right UKRP, can definitely make all the difference when it comes to placing and maintaining a new medical device on the market so medical device manufacturers should pick a trusted partner, and preferably one that shares their vision, to support them in their business journey. That’s why we all agreed a new web site would be the perfect way to give companies access to useful resources and information, as well as offering our direct support and UKRP services,” concludes Burton.
For more information visit www.ukrp.org
Exhibitor Data Sheet