UK medical device regulatory support covering classification, technical documentation, conformity routes, MHRA registration and market access.
Build a defensible route to the medical device market
Medical device requirements depend on the device type, classification, intended purpose, manufacturer location and destination market. Conformity Services helps manufacturers and suppliers structure the evidence and responsibilities needed for a controlled market-entry project.
How Conformity Services can help
- Review device classification, intended purpose and regulatory route.
- Perform gap assessments of technical documentation and declarations.
- Support essential requirements or general safety and performance requirements mapping.
- Coordinate UK Responsible Person or Authorised Representative arrangements where applicable.
- Support MHRA registration preparation and maintenance for Great Britain.
- Review labels, instructions for use, claims and post-market documentation.
Key areas of support
Classification and conformity strategy
We help clarify the applicable framework and the evidence expected for the device and market. Where third-party conformity assessment is required, we help prepare the file and coordinate actions; certification decisions remain with the relevant approved or notified body.
Technical documentation
Support can cover device descriptions, design and manufacturing information, risk management, verification and validation evidence, clinical or performance documentation, labelling, declarations and post-market arrangements. Scope is tailored to the device and lifecycle stage.
UK market access and registration
Medical devices placed on the Great Britain market generally need to comply with the UK Medical Devices Regulations 2002 and be registered with the MHRA. Non-UK manufacturers need an appropriately appointed UK Responsible Person. Northern Ireland follows a different route.
Our approach
- Confirm device, intended purpose, classification and target markets.
- Map regulatory roles and assess the available evidence.
- Issue a prioritised remediation plan.
- Support documentation, registration preparation and ongoing control.
Relevant services
Explore our Authorised Representative services, technical documentation support and market access services.
Discuss your medical device project
Tell us the device type, current evidence, manufacturer location and intended markets. We will define an appropriate support scope. MHRA registration is not approval, certification or endorsement.
Book a medical device compliance consultation
Frequently asked questions
Can you determine the classification and regulatory route for our medical device?
We can review the intended purpose, design, claims, users and market to advise on classification and the likely conformity route. Complex or borderline products may require additional specialist or authority input.
Can Conformity Services help with MHRA registration?
Yes. We can help confirm the information and documentation needed, support UK Responsible Person arrangements where applicable, and prepare or maintain the registration submission. Registration is not approval, certification or endorsement by the MHRA.
Do you review medical-device technical documentation?
Yes. We can assess device descriptions, risk management, verification and validation evidence, clinical or performance documentation, labels, declarations and post-market arrangements, then provide a prioritised remediation plan.