How AF Pharma’s UKRP Services Supported a Norwegian Medical Device Company’s UK Expansion
As the UK market becomes increasingly attractive for European medical device manufacturers, navigating the unique post-Brexit requirements is essential. One of these critical requirements is the need for a UK Responsible Person (UKRP). Recently, a Norway-based manufacturer partnered with AF Pharma as their UKRP, ensuring smooth UK compliance and market success.
The Challenge: Meeting UK Compliance from Norway
The Norwegian company, specializing in cutting-edge orthopedic devices, saw great demand for their products in the UK. However, entering this market posed regulatory challenges. To comply with UK law, they needed a UKRP to handle all MHRA regulatory requirements, including product registration, document management, and vigilance reporting.
The Solution: AF Pharma’s UKRP Services for Medical Devices
AF Pharma provided a seamless solution by managing the UKRP responsibilities, including documentation, labeling compliance, and acting as the primary contact with the MHRA. With our experienced team handling regulatory processes, the Norwegian company could focus on scaling their operations while entering the UK market with confidence.
Results: Growth and Compliance in the UK
Rapid Market Entry: AF Pharma’s expertise enabled the Norwegian company to meet compliance quickly, allowing their devices to launch in the UK in record time.
Increased UK Market Share: Within the first six months, they achieved a 35% growth in UK sales, driven by a strong entry strategy and regulatory compliance that built trust with UK providers.
Ongoing Compliance and Support: AF Pharma continues to support the company post-launch, handling all MHRA interactions and ensuring ongoing regulatory compliance, helping them maintain a stable UK presence.
Why Choose AF Pharma for UKRP Services?
Our UKRP services for medical devices provide essential support for companies across Europe, including:
Regulatory Expertise: Comprehensive MHRA compliance guidance.
Documentation and Labeling: Complete document management for the UK market.
Trusted UK Contact: Serving as the primary MHRA contact for all regulatory matters.
Post-Market Surveillance: Support for post-launch vigilance, ensuring ongoing compliance.
Grow Your Medical Device Business in the UK with AF Pharma
If you’re a medical device manufacturer in Norway or elsewhere in Europe, AF Pharma’s UKRP services can help you navigate the UK market successfully. Contact us today to discuss how we can support your UK expansion.
コメント