MHRA Medical Device Registration Services
Helping overseas manufacturers register medical devices with the MHRA and access the UK market through compliant UK Responsible Person (UKRP) services.
What is MHRA Medical Device Registration?
Medical devices placed on the Great Britain market must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA). Overseas manufacturers must appoint a UK Responsible Person (UKRP) who acts as the regulatory representative and assists with device registration and ongoing compliance obligations.
Medical Devices We Support
Class I Medical Devices
Class IIa Medical Devices
Class IIb Medical Devices
Class III Medical Devices
In Vitro Diagnostic Devices (IVDs)
Step 1 – Initial Consultation
Discuss device classification and registration requirements.
Step 2 – Documentation Review
Review technical file and supporting documentation.
Step 3 – UKRP Appointment
Formal appointment as UK Responsible Person.
Step 4 – MHRA Registration
Submission of required registration information.
Step 5 – Ongoing Compliance
Support with ongoing compliance obligations.
Documents Required for MHRA Registration
| Document | Purpose |
|---|---|
| Declaration of Conformity (DoC) | Confirms conformity with applicable regulatory requirements |
| Device Description | Provides details of the medical device and intended purpose |
| Labelling & Packaging Information | Demonstrates compliance with UK labelling requirements |
| Instructions for Use (IFU) | Provides user guidance and safety information |
| Technical Documentation | Supports device safety, performance and regulatory compliance |
| Clinical Evaluation Documentation | Required where applicable to demonstrate clinical performance |
| Risk Management Documentation | Evidence of risk assessment and control measures |
| UK Responsible Person Details | Required for overseas manufacturers placing devices on the UK market |
The specific documentation requirements may vary depending on the device classification, intended purpose and applicable regulatory pathway. Accurate Assessments can review your documentation and identify any gaps prior to MHRA registration.
Why Choose Accurate Assessments?
Regulatory Expertise You Can Trust
- Over 15 years of regulatory compliance experience
- Extensive experience supporting regulated healthcare products
- MHRA inspection experience
- UK Responsible Person (UKRP) services for overseas manufacturers
- Medical Device and IVD regulatory support
- Cosmetic Responsible Person services
- Practical, commercially focused compliance advice
- Personalised support from an experienced regulatory professional
- Assistance throughout the product lifecycle, from market entry to ongoing compliance
We work with manufacturers, importers and distributors seeking reliable regulatory support to access and maintain products on the UK market.
FAQ Section
What is MHRA Medical Device Registration?
Medical devices placed on the Great Britain market must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with applicable UK regulatory requirements.
Do overseas manufacturers need a UK Responsible Person?
Yes. Manufacturers located outside the UK must appoint a UK Responsible Person (UKRP) to act on their behalf and fulfil specific regulatory obligations.
Which medical devices require MHRA registration?
Most medical devices, including Class I, Class IIa, Class IIb, Class III devices and certain IVDs, require registration before being placed on the Great Britain market.
How long does MHRA registration take?
Timescales vary depending on device classification, documentation readiness and regulatory requirements.
Can Accurate Assessments act as our UK Responsible Person?
Yes. We provide UK Responsible Person services for overseas medical device and IVD manufacturers seeking access to the UK market.
What documents are required for MHRA registration?
Typical requirements include a Declaration of Conformity, technical documentation, labelling information, Instructions for Use and supporting compliance documentation.
Do you support IVD manufacturers?
Yes. We provide regulatory support and UKRP services for in vitro diagnostic (IVD) manufacturers.
Can you review our technical documentation before submission?
Yes. We offer technical documentation reviews to identify potential compliance gaps before MHRA registration.