UK representative for Medical Devices and IVDs
Ensuring Compliance and Market Access in the United Kingdom
At GBA Key2Compliance, we understand the challenges of entering and maintaining access to the UK market, especially following the divergence from EU medical device regulations. Our team offers comprehensive UK Responsible Person (UKRP) support, acting on your behalf as the essential regulatory contact within the UK.
We guide you through every step of device registration with the MHRA, review your technical documentation and declarations of conformity for compliance, and ensure ongoing readiness for audits or inspections. By serving as your UKRP, we facilitate communication with UK authorities, coordinate incident reporting, support post-market surveillance, and keep you up to date with the latest regulatory developments – providing you with peace of mind and a smooth path to UK market access.
The UKRP’s main responsibilities include:
- Registering devices with the UK Medicines and Healthcare products Regulatory Agency (MHRA)
- Ensuring technical documentation and declarations of conformity are available for inspection
- Acting as a point of contact between manufacturers and UK authorities
- Coordinating incident reporting and vigilance activities
- Supporting post-market surveillance and regulatory updates
For medical device and IVD companies, having a UKRP is not just a legal requirement but a crucial step in maintaining continuous and compliant access to the UK market. The UKRP provides confidence to regulators, patients, and business partners by representing the manufacturer’s commitment to safety, transparency, and regulatory compliance in the UK.