UK Medical Device Registration

UK Medical Device Registration in Great Britain: MHRA, UKCA, UK Responsible Person (UKRP) and DORS Requirements

Manufacturers planning UK Medical Device Registration for the Great Britain (GB) market must first ensure that their regulatory foundations are in order, beginning with the status of their UK Responsible Person (UKRP). As of 30 March 2026, all former Great Britain-based Authorised Representative accounts in the MHRA's Device Online Registration System (DORS) were required to have transitioned to UK Responsible Person (UKRP) accounts. Accounts that were not updated by this deadline have since been closed and cannot be reactivated; affected organizations must instead create a new DORS account before proceeding. Manufacturers are therefore advised to confirm, as a first step, that their UKRP maintains an active and correctly transitioned DORS account before initiating any new device registration.

The Two-Territory Structure You're Actually Working Within

The UK isn't a single regulatory territory for medical devices — understanding this distinction is foundational to everything else on this page:

•  Great Britain (England, Scotland, Wales): governed by UK MDR 2002, using the UKCA marking system, with MHRA as the regulator
•   Northern Ireland: continues following EU MDR and EU IVDR under the Windsor Framework, requiring CE marking, with EU Notified Body involvement where required

These aren't two flavors of the same requirement — they're genuinely separate regulatory tracks. A manufacturer selling into both GB and Northern Ireland is, in practical terms, running two parallel compliance programs, even though both ultimately sit under the same UK government.

The Core Registration Steps for Great Britain

The UK Medical Device Registration process involves several key steps to help manufacturers meet applicable regulatory requirements before entering the Great Britain market.

•   Classify your device: Class I, IIa, IIb, or III under UK MDR 2002, with active implantable devices following specific separate provisions.
•   Prepare technical documentation: broadly similar to MDD-era technical files, with MHRA-specific requirements layered on. Manufacturers with existing EU MDR technical files can generally adapt these for UKCA purposes, though some UK-specific differences apply.
•   Engage a UK Approved Body (UKAB) where your classification requires third-party conformity assessment, and submit your technical file or design dossier for review
  
•   Affix the UKCA marking once the UKAB issues a positive assessment and you've prepared your Declaration of Conformity.
•   Appoint a UK Responsible Person (UKRP) if you're a non-UK manufacturer — and a UK-based importer too, if your UKRP isn't also serving that role.
  
•  Register in DORS (the MHRA's Device Online Registration System) — for manufacturers established outside the UK, the UK Responsible Person (UKRP) completes the registration on the manufacturer's behalf and maintains the registration throughout the product lifecycle.
•  Receive your MHRA registration confirmation letter once the application is reviewed

The UKRP's Role and Geographic Restriction

A UK Responsible Person acts on behalf of a non-UK manufacturer to fulfill specified obligations: registering the manufacturer's devices with MHRA before market placement, maintaining technical documentation and certificates available for MHRA inspection, and promptly relaying complaints or suspected-incident reports from healthcare professionals or patients back to the manufacturer. Only one UKRP is required per manufacturer — not per device — and critically, the UKRP must be based in Great Britain specifically, not Northern Ireland. A Northern Ireland address does not satisfy this requirement, regardless of how close that might seem geographically.

Realistic Timelines

From 1 April 2026, the MHRA introduced a new annual fee structure for medical device registrations. Manufacturers are charged £300 per GMDN® Level 2 Category (or Level 1 where no Level 2 exists) each year. The previous one-off registration fee model has been replaced by this annual charging system. Manufacturers should regularly review their DORS registrations to ensure that registered devices are accurate, as annual fees are calculated based on the registered GMDN categories. The MHRA has also extended the payment deadline for the first annual fee to 31 July 2026.

Realistic Timelines

For Class I devices, registration can typically complete within 4-6 weeks. Higher-risk devices (Class IIa, IIb, III) requiring UK Approved Body involvement generally take 3-6 months or longer, with an existing CE certificate and complete technical documentation meaningfully speeding this up. MHRA itself quotes roughly 5 business days to review a straightforward, complete registration application specifically — distinct from the broader conformity assessment timeline that precedes registration.

CE Marking Transition Deadlines — and Why They Might Move

Under the current UK transitional arrangements, eligible CE-marked medical devices may continue to be placed on the Great Britain market until:

•  30 June 2028 for eligible devices certified under the Medical Devices Directive (MDD) or Active Implantable Medical Devices Directive (AIMDD).
•  30 June 2030 for eligible devices compliant with the EU Medical Devices Regulation (EU MDR) or In Vitro Diagnostic Medical Devices Regulation (EU IVDR), subject to the applicable conditions.

Manufacturers should continue monitoring MHRA guidance, as the UK is implementing broader regulatory reforms that may introduce additional market access pathways.

The International Reliance Framework: A Genuinely Significant Upcoming Change

The MHRA continues to develop an international recognition approach for medical devices as part of the UK's wider medical device regulatory reform programme. The objective is to allow the MHRA to make greater use of approvals from trusted international regulators where appropriate, reducing unnecessary duplication while maintaining UK safety standards. As of July 2026, the detailed framework for medical devices has not yet been fully implemented, and manufacturers should continue to comply with existing UKCA or applicable CE transitional requirements until further MHRA guidance is published.