Episode Details

Since Brexit, non-UK medical device manufacturers need a UK Responsible Person (UKRP) to access the Great Britain market. While appointing a local distributor for this role is a common shortcut, it creates a significant conflict of interest between sales and regulatory compliance. This episode explores the hidden risks of this approach—from a lack of regulatory expertise to giving a commercial partner leverage over your market access—and makes the case for appointing a specialized, independent UKRP for long-term business security and continuity. • What is the UK Responsible Person (UKRP) and why is it mandatory after Brexit? • Why is appointing a distributor as your UKRP a potential conflict of interest? • How could a distributor's sales focus compromise your regulatory compliance? • Does your distributor possess the necessary expertise to engage with the MHRA? • What happens to your market access if you end your agreement with a distributor who is also your UKRP? • How does using a distributor as your UKRP risk your confidential technical files? • What are the key advantages of appointing a dedicated, independent UKRP? • How does separating regulatory and commercial functions provide business flexibility? • Is your current UKRP strategy built for long-term success or short-term convenience? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.