UK Medical Device Registration with
MHRA & UKCA Compliance Services

Achieve UKCA Compliance. Register with MHRA. Enter the UK Market with Confidence.

End-to-end UK medical device Regulatory support for Class I–III medical devices & IVD manufacturers.

Talk to a UK Specialist

Trusted UK Medical Device Regulatory Partner

  • 20+ years of Global Regulatory Expertise
  • UKCA Marking Support & MHRA Registration
  • UK Approved Body Liaison
  • UK Responsible Person (UKRP) Services
  • GB & Northern Ireland Regulatory Routes
  • Post-Brexit Transition Expertise
  • Dedicated UK Regulatory Specialists
  • Experience Across All Medical Device Classes

UKCA Marking Support & MHRA Registration

Register Your Medical Device in the UK – Faster & Compliant

We support manufacturers with UK medical device registration, MHRA submissions, and UKCA certification strategies to ensure compliant and timely UK market access.

Our MHRA & UKCA Services Include

  • UK Approved Body Identification & Liaison
  • UKCA Marking Strategy & Certification Support
  • GB vs NI Regulatory Pathway Guidance
  • Technical File & Audit-Ready Documentation
  • CE to UKCA Transition & Gap Assessment
  • Legal representation for non-UK manufacturers
  • MHRA Medical Device Registration & Notification

Device Coverage

Class I, IIa, IIb, III & IVD medical devices

Register with MHRA

Get Expert Support 

Success Stories

 

Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.

Regulatory Affairs
Arie Henkin

VP - Quality and Regulatory, Australia -based, Leading SaMD Company

Medical Devices

Registration and LR Support

Global

 

I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.

Regulatory Affairs
Darren Mansell

Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company

Medical Devices

Swiss Rep Services

Japan and Switzerland

 

Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.

Regulatory Affairs
Robert Menadue

Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company

Medical Devices

Registration and AR Services

Malaysia and Indonesia

 

We are impressed with Freyr’s support in providing us with quick and well-detailed solutions to our queries. Freyr’s constant support to adapt to ever-changing Regulatory conditions while providing support with any additional queries we had in a timely manner has truly impressed us.

Regulatory Affairs
Sergey Burlov

Quality Manager, Russia-based, Innovative SaMD Company

Medical Devices

Registration and LR Services

Brazil

 

FREYR has accompanied us with the registration of several products on the UK market. They have always been quick to reply, attentive to our needs, a great source of Regulatory information and support. The price is reasonable compared with other similar service providers. We particularly appreciate the personalized quarterly and annual status reports that Freyr provides. When we call on FREYR, we know they will do their best to satisfy our needs, and that customer satisfaction is a priority.

Regulatory Affairs
Pascale LE BAUD

Regulatory Affairs Associate - RA Department, France-based, Leading Synthetic Implants Manufacturing Company

Medical Devices

UKRP Support

UK

UK Medical Device Compliance – Made Simple

Navigating UK medical device compliance can be complex post-Brexit. Freyr simplifies

  • GB Medical Device Registration (UKCA) Requirements
  • Northern Ireland (CE / UKNI) Obligations
  • UKCA Certification
  • Post-market Surveillance & Vigilance

Faster UK Market Entry with Minimized Regulatory Risk.

UK Responsible Person (UKRP) Services

Appoint a UK Responsible Person with Confidence. Non-UK manufacturers must appoint a UK Responsible Person (UKRP) to legally place devices on the Great Britain market. Freyr can act as your trusted UKRP partner.

Our UKRP Services Cover

  • UK Responsible Person Appointment
  • UKRP for Medical Devices & IVDs
  • MHRA Registration
  • Labelling & IFU Compliance Support
  • Post-Market Surveillance & Vigilance
  • Authority Communication on Your Behalf
  • UKRP vs EU Authorised Representative Guidance
    • Clear SLAs
    • Transparent pricing
    • Dedicated UK regulatory experts

Speak to a UKRP Expert 

Our UK Medical Device Registration Process

A simplified, risk-free approach

Why Choose Freyr for UK Medical Device Registration?

  • Proven UK & EU Regulatory expertise
  • Faster approvals through right-first-time submissions
  • Experience with GB & NI compliance routes
  • Scalable support for startups & global manufacturers
  • Single partner for UK, EU & global registrations
  • Audit-ready, regulator-aligned documentation

UK Regulatory Expertise Across Device Types

We support registrations for

  • General medical devices
  • In-vitro diagnostics (IVDs)
  • Software as a Medical Device (SaMD)
  • Combination products