Ensure smooth UKCA compliance with Regen Marketing Limited. We support international medical device companies by managing UK Medical Device Registration and UKRP responsibilities. Our approach is ideal for niche and affordable devices, offering reliable, budget-friendly solutions.

23 June 2025

London

UK medical device registration is a mandatory process for manufacturers looking to market their devices in Great Britain. Following Brexit, all medical devices must comply with UK regulations and obtain UKCA (UK Conformity Assessed) marking. UKCA registration confirms that a device meets the safety and performance requirements outlined by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Manufacturers outside the UK must appoint a UK Responsible Person (UKRP) to handle compliance, technical documentation, and communication with the MHRA. Timely and accurate registration ensures uninterrupted market access, helping to maintain product credibility and legal compliance in the UK healthcare sector.

Regen Marketing Limited is a trusted compliance partner for international medical device manufacturers seeking to access the UK market. We offer cost-effective UK Responsible Person (UKRP) services and expert support for UKCA registration. Our focus is on niche, low-volume, or budget-friendly medical devices, ensuring a smooth path to compliance with UK MHRA regulations. Acting independently from sales agents or distributors, we offer flexibility, transparency, and tailored assistance. From managing technical documentation to coordinating with the MHRA and supplying device samples if needed, our team ensures complete compliance. We also offer a commission-based model to ease market entry costs. With responsive service and regulatory expertise, Regen Marketing makes UK compliance straightforward, affordable, and efficient for global manufacturers.

Why Choose Us?

1. We communicate directly with the MHRA and manage compliance responsibilities on your behalf.
2. We securely hold product samples and ensure regulatory obligations are met.
3. Our services are independent of your distributors, giving you full control over sales partnerships.
4. Transparent, affordable consultancy fees make it easy to plan your compliance budget.
5. A unique commission-based model helps reduce your initial entry costs into the market.
6. We provide full support to streamline and complete your UK medical device registration process.
7. Flexible, efficient, and responsive service tailored to low-volume and niche medical devices.

About Us

Founded in 2005, Regen Marketing Limited partners with international medical device manufacturers to offer expert UK Responsible Person (UKRP) support and UKCA registration services. We specialise in assisting companies with niche, low-volume, or cost-effective medical devices to achieve regulatory compliance in the UK. As your UKRP, we liaise with the MHRA, maintain essential documentation, support product conformity checks, and ensure fast access to samples when required, making your UK market entry smooth and compliant.

Contact Us

Mail: [email protected]