UK MHRA Medical Device Registration

Entering the UK medical device market requires careful navigation through the Medicines and Healthcare products Regulatory Agency (MHRA) requirements. Masuu Global Solutions streamlines the registration journey by reviewing your technical documentation, preparing compliant submissions through the Device Online Registration System (DORS), and ensuring that your products meet all UK‑specific regulatory expectations.

As an experienced UK Responsible Person (UKRP), Masuu acts as your official representative to the MHRA managing registrations, post‑market surveillance, vigilance communication, and CE‑to‑UKCA transitions. Our team keeps you updated with regulatory developments while ensuring your device remains compliant throughout its lifecycle.

Ensuring Seamless Compliance with UK MDR & MHRA Requirements

Foreign manufacturers placing devices on the UK market must comply with the UK Medical Devices Regulations 2002 (as amended). All medical devices and IVDs must be registered with MHRA before commercialization. Non‑UK manufacturers are legally required to appoint a UK Responsible Person (UKRP) to act on their behalf.

With evolving UK requirements including new guidance from the MHRA’s regulatory reform consultation—manufacturers often face challenges such as:
  • Unclear CE‑to‑UKCA transition requirements
  • Data gaps and incomplete technical files
  • Device reclassification and documentation updates
  • Learning to navigate the DORS registration platform

Masuu Global Solutions removes these barriers. We manage the entire UK registration process, verify documentation, handle all MHRA interactions, and ensure you remain compliant throughout product launch and post‑market stages.

Step-by-Step UK Medical Device Registration Process

Masuu manages the entire UK registration workflow, including:
  1. Device classification and regulatory pathway assessment
  2. UKRP appointment and legal representation setup
  3. Technical documentation & labeling review
  4. DORS registration & submission management
  5. UKCA or CE certificate verification
  6. Compliance check for PMS, vigilance, and QMS requirements
  7. Ongoing regulatory monitoring & support
Typical processing time: 2–6 weeks depending on device type and dossier completeness.

Masuu UK Medical Device Registration – Key Offerings

Device Registration (DORS)

We handle full MHRA device registration, ensuring accurate listings, compliant submissions, and timely approvals for all device classes.

UK Responsible Person (UKRP) Services

As your UKRP, Masuu:
  • Represents you legally to the MHRA
  • Maintains your documentation for inspections
  • Ensures continuous compliance
  • Oversees vigilance and PMS activities

Technical File / Dossier Compilation

We prepare UK‑aligned documentation for UKCA marking and CE‑transition readiness, ensuring audit‑ready technical files.

QMS Support

We assist in implementing and maintaining ISO 13485‑compliant quality systems tailored to UK regulatory expectations.

Regulatory Writing

Masuu prepares CERs, PMS plans, PSURs, risk management files, and other supporting documents with clarity and regulatory precision.

Labeling & Packaging Compliance

We ensure your labeling, packaging, and IFUs meet UKCA requirements, including language and symbol compliance.

Post‑Market Surveillance (PMS)

Masuu manages PMS plans, adverse event submissions, vigilance notifications, and MHRA communications to maintain continued market access.

Masuu UK Responsible Person (UKRP) – Service Offering

  1. Device Registration with MHRA
    2. We manage your complete registration through DORS, ensuring correct listings and smooth approval.
  1. Documentation & Conformity Assurance
    2. We verify and maintain:
    • Declarations of Conformity
    • Technical documentation
    • CE/UKCA product certifications
    • All files required for MHRA audit requests
  1. Responding to MHRA Queries
    2. We handle all MHRA queries, follow‑ups, and clarifications on your behalf to ensure prompt resolution.
  1. Vigilance & Safety Communication
    2. As your primary liaison, we coordinate all safety‑related reports, including FSCA, incident updates, and adverse event communication.
  1. Inspection & Audit Readiness
    2. Masuu ensures all records, labeling proof, PMS documentation, and technical files remain audit‑ready and fully compliant.

Why Partner with Masuu Global Solutions?

  • End‑to‑end regulatory expertise across pre‑market, post‑market, and lifecycle compliance
  • A proven history of supporting 1500+ device registrations across multiple categories
  • Local presence in the UK with dedicated regulatory specialists
  • Strategic guidance for seamless CE → UKCA transition
  • Direct MHRA liaison for faster communication and approvals
  • Trusted by hundreds of global manufacturers as their long‑term UK regulatory partner
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