MHRA Registration Services
Comprehensive support for medical device registration with the UK Medicines and Healthcare products Regulatory Agency, ensuring compliance with UK regulations.
What is MHRA Registration?
MHRA (Medicines and Healthcare products Regulatory Agency) registration is required for medical devices to be legally marketed in the United Kingdom. Following Brexit, the UK has established its own regulatory framework for medical devices, separate from the EU system.
Our MHRA registration services guide manufacturers through the UK's regulatory requirements, including the UKCA marking system, ensuring compliance and market access in the United Kingdom.
Key Benefits of MHRA Registration
- Access to the UK medical device market
- Compliance with UK regulatory requirements
- UKCA marking eligibility for medical devices
- Clear pathway for post-Brexit market access
Our MHRA Registration Process
A structured approach to navigating UK medical device regulatory requirements
Regulatory Assessment
Evaluate your device against UK regulations, determining the appropriate conformity assessment route and classification.
Technical File Preparation
Prepare and compile all required technical documentation to meet UKCA marking requirements and MHRA standards.
Conformity Assessment
Coordinate conformity assessment with UK Approved Bodies for devices requiring third-party evaluation.
UK Responsible Person
Establish a UK Responsible Person (UKRP) as required for non-UK manufacturers to act as a local representative.
Registration Submission
Submit device registration to MHRA through the appropriate channels, including all required documentation.
UKCA Marking & Compliance
Guide implementation of UKCA marking and ongoing compliance with MHRA post-market surveillance requirements.
Why Choose Our MHRA Registration Services
Our expertise ensures a smooth path to market entry in the United Kingdom
UK Regulatory Expertise
Deep understanding of post-Brexit UK medical device regulations and MHRA requirements.
UK Approved Body Relationships
Established connections with UK Approved Bodies to streamline the conformity assessment process.
UK Responsible Person Network
Access to qualified UK Responsible Persons for non-UK manufacturers requiring a local representative.
Regulatory Transition Support
Expert guidance for transitioning from EU CE marking to UKCA marking requirements.
Ready to Enter the UK Market?
Our MHRA experts will guide you through the entire registration process, ensuring compliance with UK regulations and accelerating your market access.
Get Your MHRA Registration Consultation