Access the UK Market with Ease – Partner with Us as Your UK Responsible Person (UKRP)

The UK Medical Device Regulations (UK MDR 2002) mandated that all medical device manufacturers outside the UK must designate a UK Responsible Person (UKRP). This requirement is critical for enabling the sale of medical devices in the Great Britain market (England, Scotland, and Wales).

We offer a seamless solution to ensure compliance with these regulations, allowing you to focus on what matters most – innovating and delivering high-quality medical devices to the market.

Our Responsibilities as Your UKRP

When you appoint us as your UK Responsible Person, we will handle all regulatory aspects with the Medicines and Healthcare Products Regulatory Agency (MHRA) on your behalf. Our comprehensive services include:

Regulatory Compliance

• Device Registration: We will register your devices with the MHRA, ensuring they meet all legal and regulatory requirements for placement in the UK market.

• Documentation Management: We will ensure that your Regulatory Documents are properly prepared and compliant with applicable UK regulations.

Ongoing Support

• Documentation Retention: We will securely retain a copy of your technical documentation and make it available for MHRA inspection whenever required.

• Prompt Communication: We will provide any requested information to the MHRA promptly, ensuring smooth regulatory processes.

• Incident Reporting: We will promptly inform you of any complaints or incidents related to your devices, helping you maintain safety and quality standards.

Local Representation

• Acting as Your Representative: We will serve as your official point of contact within the UK for regulatory matters, facilitating clear communication with the MHRA and other relevant authorities.

Why Choose Us as Your UKRP?

• Expertise: We are experienced in navigating UK regulatory requirements, ensuring that your devices comply with all legal obligations.

• Reliability: Our prompt and transparent approach ensures that all MHRA interactions are handled efficiently.

• Partnership: As your UKRP, we will act as an extension of your business, providing you with the peace of mind needed to succeed in the UK market.

Are You Ready to Access the UK Market?

With the UKRP requirement in full effect, the time to act is now. Let us simplify the process and help you achieve your regulatory goals.

Please get in touch with us today to discuss how we can support your business in meeting UK regulatory standards and successfully entering the Great Britain market. Together, we can ensure your devices confidently reach patients and healthcare professionals across the UK.