UK Responsible Person: Essential Guide for Medical Device Manufacturers
7 min read
Post-Brexit regulations have introduced new requirements for medical device manufacturers wanting to place their products on the UK market. A UK Responsible Person (UKRP) is now mandatory for non-UK manufacturers.
Understanding the UKRP Role
The UK Responsible Person serves as your local representative in the United Kingdom, taking responsibility for:
- Registration of devices with the MHRA
- Compliance with UK medical device regulations
- Communication with UK authorities
- Post-market surveillance activities
- Handling of vigilance reporting
Key Responsibilities
A UKRP's duties include:
- Device Registration
- Managing MHRA registrations
- Maintaining accurate documentation
- Ensuring timely updates
- Regulatory Compliance
- Verifying technical documentation
- Ensuring UKCA marking requirements are met
- Monitoring regulatory changes
- Safety Monitoring
- Incident reporting to MHRA
- Coordinating with manufacturers
- Managing field safety notices
Expert UKRP Services at Advena Medical
At Advena Medical, we provide comprehensive UKRP services:
- Full MHRA registration management
- Technical documentation review
- Vigilance reporting
- Post-market surveillance
- Regulatory guidance and support
- Direct communication with UK authorities
Why Choose Professional UKRP Services?
Working with an experienced UKRP partner ensures:
- Seamless UK market access
- Full regulatory compliance
- Expert handling of MHRA communications
- Efficient incident management
- Peace of mind for manufacturers
Getting Started
Ready to secure your UK market access? Visit our UK Responsible Person services page to learn how we can support your regulatory compliance needs in the United Kingdom.