In today’s evolving regulatory landscape, medical device manufacturers worldwide face increasing demands to meet stringent UK requirements. This is especially true for companies from the EU, as post-Brexit changes now require an appointed UK Responsible Person (UKRP) to support compliance for devices marketed in the UK. At AF Pharma, our UKRP services for medical devices have proven essential in helping European businesses not only navigate these requirements but also accelerate growth in a key market. Here, we share the success stories of two clients – one based in Poland and another in Sweden – who chose AF Pharma as their UKRP partner and reaped the benefits to provide the services of UKRP for medical devices.
A Polish Medical Device Manufacturer: A Fast-Track to UK Compliance and Growth
One of our clients, a leading Polish manufacturer specializing in advanced diagnostic devices, initially faced challenges adapting to UK regulatory requirements. With innovative devices focused on early-stage disease detection, their products already met the EU’s rigorous standards. However, entering the UK market required an appointed UKRP, a process with extensive regulatory requirements and complex documentation.
When the Polish company reached out to AF Pharma, our team immediately streamlined their compliance pathway. We handled every stage of the UKRP process, from ensuring proper documentation and labeling requirements to acting as their official point of contact for the MHRA (Medicines and Healthcare products Regulatory Agency). With AF Pharma's support, this company quickly achieved compliance, allowing them to bring their devices to market in record time.
As a result, they saw a 25% increase in UK sales within the first year of partnership. This success story shows how a proactive approach to UKRP services can drive growth for ambitious companies across Europe.
Supporting Swedish Innovation: A Pathway to Expanded UK Market Reach
AF Pharma’s commitment to fostering growth extended to a client based in Sweden, a company specializing in orthopedic devices designed to enhance recovery and improve patient outcomes. Despite having strong demand in the EU, this Swedish manufacturer struggled with UK entry due to Brexit-related regulatory hurdles. The team at AF Pharma stepped in to bridge the gap, delivering reliable UKRP services for their range of products.
Our experienced regulatory team ensured that all device registrations and labeling complied with MHRA standards. Additionally, AF Pharma offered guidance on post-market surveillance and vigilance reporting, which are crucial for ensuring ongoing compliance in the UK market. Thanks to our comprehensive UKRP services, this Swedish manufacturer not only entered the UK market but also expanded their reach, ultimately boosting their revenue by 30% over two years.
Why AF Pharma as UKRP for medical devices?
Our success with these companies from Poland and Sweden underscores why AF Pharma is a trusted UKRP for medical devices. We prioritize a seamless compliance experience, handling all regulatory details so that companies can focus on what matters most: advancing healthcare and reaching patients.
AF Pharma’s UKRP services for medical devices support manufacturers with:
Full Regulatory Compliance: Comprehensive support in meeting MHRA’s requirements.
Documentation Management: Assistance with labeling, product registrations, and document retention.
Market Responsiveness: Efficient navigation of post-market requirements, so clients can quickly adapt to any regulatory updates.
Dedicated Support: Acting as an official point of contact for the MHRA on behalf of our clients, addressing inquiries promptly and effectively.
If you’re a medical device manufacturer in Poland, Sweden, or any other country looking to enter the UK market, AF Pharma’s UKRP services for medical devices offer the expertise you need to succeed. Contact us today to discuss how we can help your business grow in the UK.
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