For aesthetics brands entering or operating in the UK, compliance is not optional—it is the foundation of credibility and safety. The role of the UK Responsible Person (UKRP) has become critical in the post-Brexit regulatory landscape.
The UKRP acts as the primary point of contact between a manufacturer and the UK regulatory authorities (MHRA). Their responsibilities include ensuring technical documentation is in order, vigilance reporting, and ensuring that all devices meets local safety standards before they reach the clinic floor.
Comparing EU and UK Requirements
While the UK system still mirrors many aspects of the EU MDR, divergence is happening. Specific labeling requirements, registration timelines, and vigilance reporting pathways now differ. Navigating this can be complex for international manufacturers.
Having a knowledgeable UKRP is about more than just ticking boxes; it is about risk mitigation. A robust compliance strategy ensures supply chain continuity and protects both the brand and the practitioner from legal and reputational risks.
At Sirona, we ensure that every product we distribute is fully compliant with the latest UK regulations, giving our partner clinics complete peace of mind to focus on what matters most: patient care.