Expanding into the UK market presents unique challenges for medical device manufacturers, especially for companies outside of Europe. One essential requirement for non-UK manufacturers is appointing a UK Responsible Person (UKRP) to ensure regulatory compliance. Recently, a leading medical device manufacturer based in the United States partnered with AF Pharma to fulfill this critical role – and the results have been remarkable.
The Challenge: Navigating UK Compliance from the U.S.
This U.S.-based company, known for its innovative respiratory devices, was eager to enter the UK market. While their products met FDA standards in the United States, the UK’s requirements, including those set by the Medicines and Healthcare products Regulatory Agency (MHRA), introduced new regulatory hurdles. With no UK presence, they needed an experienced partner to act as their UKRP, ensuring compliance with MHRA regulations while managing product registration, labeling, and vigilance requirements.
The Solution: AF Pharma’s UKRP Services for Medical Devices
By choosing AF Pharma as their UKRP, the U.S. manufacturer gained a trusted partner with in-depth regulatory expertise. Our team took charge of the UK regulatory pathway, handling documentation, acting as the point of contact with the MHRA, and overseeing all compliance activities. This enabled the client to focus on product innovation and market strategies, while AF Pharma streamlined the regulatory process.
Key Outcomes of AF Pharma’s UKRP Partnership
Fast-Track Market Entry: Thanks to AF Pharma’s UKRP services for medical devices, the company achieved a faster-than-expected entry into the UK market. Our regulatory team ensured the devices met all MHRA requirements, allowing them to launch within months.
Increased Sales and Brand Visibility: Within the first year, the U.S. manufacturer saw a 40% boost in UK sales. AF Pharma’s UKRP support not only helped with regulatory matters but also gave their brand increased credibility, allowing them to establish a strong foothold in the UK.
Ongoing Compliance and Peace of Mind: As their UKRP, AF Pharma continues to provide post-market support, handling vigilance reporting and serving as the official contact for the MHRA. This ongoing support ensures their compliance remains up-to-date, reducing risks and enhancing trust with UK healthcare providers and patients.
Why Choose AF Pharma for UKRP Services?
For international medical device manufacturers, partnering with a reliable UKRP is crucial to successful UK market entry. AF Pharma’s UKRP services provide essential support, including:
Regulatory Compliance Expertise: Our team ensures all devices meet MHRA standards.
Complete Documentation and Labeling Support: We manage the paperwork and labeling needed for compliance.
Efficient Regulatory Communication: As the official UKRP, AF Pharma serves as the MHRA’s primary contact, responding quickly to any regulatory inquiries.
Post-Market Support: From vigilance reporting to ongoing regulatory updates, we handle compliance beyond market entry.
Ready to Expand Your Medical Device Business to the UK?
At AF Pharma, our UKRP services for medical devices help manufacturers from the U.S. and worldwide access the UK market with confidence. Contact us today to learn how our expert team can support your business’s growth in the UK, ensuring compliance every step of the way.
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