Brexit brought major regulatory changes for International Medical Device companies wanting to enter the UK market.
Manufacturers based outside the UK must appoint a UK-based Responsible Person (UKRP), and achieve UKCA registration as part of their compliance process.
What Does a UK Responsible Person Do?
Your UKRP ensures you comply with UK regulatory standards, manages documentation, in many cases holds samples and maintains a direct link with the MHRA. As your UK RP Regen Marketing will also register new devices and manage your existing registrations, and handle any MHRA queries. For MHRA, the UKRP must ensure the product has a valid declaration of conformity, technical files, and access to any necessary certifications. UKCA registration services assist in ensuring everything is submitted accurately and on time.
Key Responsibilities Outlined by the MHRA
As per MHRA guidelines, the UK Responsible Person must:
- Register all new or existing medical devices with the MHRA.
- Keep a copy of the declaration of conformity and all technical documentation.
- Provide the MHRA with the required information to show the device’s compliance.
- Coordinate if the MHRA requests device samples or access.
- Report any post-market complaints or safety issues immediately.
When applying for MHRA UK responsible person registration, these duties must be clearly understood and followed.
Post-Market Monitoring
The UKRP must also ensure that post-market surveillance systems are in place. Any reports from healthcare professionals, patients, or users must be communicated to both the manufacturer and MHRA without delay. Additionally, if a manufacturer fails to meet their obligations, the UKRP is legally required to terminate the relationship and notify the MHRA.
Conclusion
Breaking into the UK medical device market doesn’t have to be a legal maze. With proper support, MHRA UK responsible person registration is just another step toward getting your products into the hands of those who need them. Instead of juggling endless forms and guidelines, let experts in UKCA registration services simplify the path for you. When compliance is taken care of, you get more time to innovate, grow, and focus on the people your products are made for. That’s how you turn regulation into opportunity—with confidence and clarity every step of the way.