What is MHRA Registration?
MHRA Registration is the act of formally notifying the government that you intend to place a medical device or IVD on the Great Britain market (England, Wales and Scotland). It is submitted and managed through the Device Online Registration System, known as DORS.
Registration is distinct from certification. It does not mean your device has been approved or accredited but it means you have notified the regulator and your device is legally listed. Manufacturers must not use MHRA logos or claim MHRA approval based on registration alone.
Role of the MHRA: The Medicines and Healthcare Products Regulatory Agency (MHRA) is the UK government’s competent authority for medical devices, medicines and IVDs. It oversees market access, post-market surveillance, adverse event reporting, and enforcement for all devices sold in Great Britain.
MHRA Registration vs UKCA Certification — key difference : UKCA Certification is the conformity assessment process proving your device meets UK safety standards (equivalent to CE Marking for the EU). The registration is the administrative step of listing your certified device in the UK database before market placement. Both are required, means certification first, registration second.
I3CGlobal is a registered UK business and active UKRP for medical device manufacturers across 30+ countries.
UK MHRA Registration service for medical devices. Expert compliance guidance for non UK Manufacturers. Get your MHRA Registration done right!
MHRA Registration for Medical Devices and IVDs in the UK
UK MHRA Registration is the mandatory process for listing all medical devices and in vitro diagnostics (IVDs) with the Medicines and Healthcare Products Regulatory Agency before they can be legally sold in Great Britain. As per UK Medical Devices Regulations 2002, registration is compulsory for all device classes since 1 January 2021 after Brexit and the UK’s departure from EU regulatory frameworks.
Without valid registration, no medical device or IVD can lawfully be placed on the UK market. Failure to register carries legal consequences including product removal and potential enforcement action by the enforcement agency.
Any business that manufactures, imports, distributes or rebrands medical devices or IVDs for the Great Britain market must register with the MHRA. Specifically, you must register if your company:
- Manufactures Class I, IIa, IIb or III medical devices for the UK market
- Rebrands or relabels devices under your own name
- Assembles system or procedure packs that contain a medical device
- Manufactures or imports IVDs of any class for sale in Great Britain
- Imports devices for performance evaluation
UK based Manufacturers: UK manufacturers can register directly with the MHRA via DORS. No intermediary is required. You create a DORS account in your company name and submit registrations directly.
Non-UK / foreign manufacturers : All manufacturers based outside the UK must appoint a UK Responsible Person before placing any device on the Great Britain market. That person / organization must be a legally recognized entity based in the UK that registers the device on the manufacturer’s behalf, holds technical documentation, and liaises with authorities.
UK MHRA Registration by Device Classification
Device classification under UK MDR 2002 determines the conformity assessment route required before registration. Higher-risk classes require third-party assessment by a UK Approved Body (UKAB).
| Device class | Risk level | Conformity route for MHRA Registration | Assessment type |
|---|---|---|---|
| Class I (non-sterile, non-measuring) | Low | Declaration of Conformity only — self-certification | Self-certify |
| Class I (sterile or measuring) | Low–Medium | UK Approved Body involvement required | UKAB required |
| Class IIa | Medium | UK Approved Body certificate required | UKAB required |
| Class IIb | Medium-High | UK Approved Body certificate required | UKAB required |
| Class III | High | UK Approved Body Design Dossier review + certificate required | UKAB required |
| IVD — General (Class A) | Low | Declaration of Conformity only — self-certification | Self-certify |
| IVD — Class B, C, D | Medium–High | UK Approved Body involvement required | UKAB required |
Step-by-Step Registration Process with UK Authorities
The MHRA Registration process follows a defined sequence from manufacturer setup to official registration confirmation. The flowchart below (see diagram in this document) illustrates the full process at a glance. The steps are:
Classify Your Medical Device or IVD
UK MDR 2002 — Class I, IIa, IIb, III or IVD Class A–D
Appoint a UK Responsible Person (UKRP)
Mandatory for all non-UK manufacturers — must be UK-based
Complete Conformity Assessment & Prepare Documentation
CE transitional route · MDR / IVDR · UKCA · Assign GMDN codes · Declaration of Conformity (DoC)
Create an MHRA DORS Account
Device Online Registration System — one account per organisation
Submit Device Registration via DORS
Annual fee £300 per GMDN Level 2 category (from 1 Apr 2026)
MHRA Review & Regulatory Assessment
Certificate validity · UKRP docs · GMDN accuracy — 5–15 working days
Receive MHRA Registration Approval & PARD Listing
Confirmation letter issued · device published on PARD database
Maintain Ongoing MHRA Compliance & Annual Renewals
Pay annual fee within 90 days · deregister obsolete devices · update DORS
Mandatory UK Responsible Person (UKRP) for non UK Manufacturers
Under UK MDR 2002, all manufacturers based outside the United Kingdom must designate a UK Responsible Person (UKRP) before placing any device on the Great Britain market. The UKRP is the legal point of contact between the foreign manufacturer and the MHRA, responsible for registration, documentation, post-market surveillance coordination and adverse event reporting.
I3CGlobal is registered in the United Kingdom and provides full UKRP services to medical device and IVD manufacturers worldwide. We manage DORS submissions, maintain your technical documentation, and represent you to the MHRA throughout your product’s lifecycle.
View full UKRP service details, responsibilities and timeline →
Registration Documents mandate by Authorities
The following information and documents must be submitted via DORS for a complete MHRA Registration application. Incomplete or inconsistent submissions are a leading cause of rejection and delays.
| Manufacturer and legal entity information | ||
| 1 | Legal manufacturer name, address, telephone and email (exactly as on device labelling) | Required |
| 2 | Person responsible for MHRA communications — name, email and contact details | Required |
| 3 | Mutually signed Letter of Designation (if using a UKRP) | If UKRP |
| 4 | Activity carried out by the legal manufacturer | Required |
| Device information | ||
| 5 | Medical device brand name, trade name or proprietary name | Required |
| 6 | Device model numbers and version numbers (or bulk upload spreadsheet for high volumes) | Required |
| 7 | GMDN code and term for each device | Required |
| 8 | IFU / User Manual or catalogue reference number | Required |
| 9 | UK Approved Body or Notified Body name and address (Classes IIa, IIb, III and higher-risk IVDs) | If IIa+ |
| 10 | Sterilisation method | If sterile |
| 11 | Latex and phthalates content declaration | Required |
| 12 | MRI compatibility information | If applicable |
| 13 | Basic UDI-DI (not yet enforced but increasingly required) | Recommended |
| Conformity documents | ||
| 14 | Signed and dated Declaration of Conformity (current revision) | Required |
| 15 | Technical File — latest revision number with date | Required |
| 16 | Conformity Assessment Certificates — UK Approved Body or CE certificates | If IIa+ |
Registration Fee for FY 2026
The government fee for each registration application submitted via DORS. This is separate from any UKRP service fees charged by I3CGlobal or other service providers.
Formalities for registering in UK with CE Marking
MHRA Registration requires valid conformity evidence for the route applicable to your device class. During the current transition period, CE Marking is still accepted as conformity evidence for many device classes. UKCA Marking is the long-term UK requirement.
| Device Type | CE Marking Accepted Until |
|---|---|
| Class I devices (EU MDD declaration before 26 May 2021) | 30 June 2028 |
| Class I devices (no notified body under EU MDR) | 30 June 2030 |
| Class IIa / IIb / III (valid MDD certificate) | 31 December 2027 |
| IVD general (IVDD DoC before 26 May 2022) | 30 June 2030 |
| IVD Class B, C, D — IVDD certificates | Expired 26 May 2025 — UKCA / IVDR required |
Do you need an email containing full details about UK MHRA Device Registration within 2 minutes? Just share your email below: Privacy Policy
Registration Renewal and Ongoing Manufacturer Obligations
MHRA Registration is not a one-time event. Ongoing renewal and post-market obligations must be maintained to keep your device legally on the UK market.
MHRA Registration Renewal : MHRA Registration is not a one-time event, it must be renewed one year after initial approval and every two years thereafter to maintain legal market access in the UK.
Post-Market Surveillance (PMS) Requirements : Under UK SI 2024 No. 1368 effective from 16 June 2025, manufacturers must maintain PMS Plans, PSURs, serious incident reporting procedures, and updated Manufacturer Incident Report (MIR) documentation.
Adverse Event Reporting via MORE Portal : Manufacturers and UK Responsible Persons (UKRPs) must electronically report serious incidents, FSCAs, and near-incidents through the MHRA MORE portal within mandatory reporting timelines.
Applicable Rules for Northern Ireland vs Great Britain
Different regulations apply in Great Britain (England, Wales and Scotland) and Northern Ireland. If you’re selling into both markets, the rules are different and getting this wrong is one of the most common mistakes manufacturers make.
- Great Britain — UKCA Marking + MHRA DORS Registration : England, Wales and Scotland fall under UK MDR 2002. UKCA Marking is required or CE Marking during the transitional period. All devices must be registered via MHRA DORS before going to market.
- Northern Ireland — EU Regulations, CE Marking Required : Northern Ireland stays aligned with EU medical device regulations under the Windsor Framework. CE Marking under EU MDR / EU IVDR applies. Non-EU manufacturers need a European Authorised Representative (EAR) — not a UKRP. Where a UK Approved Body is used, the UKNI mark must accompany CE Marking.
Most delays in UK market entry come down to one thing — incomplete or incorrect DORS submissions. I3CGlobal has been through this process hundreds of times. We get it right the first time.
Frequently Asked Questions
How long does UK MHRA Registration take?
The MHRA quotes 5 working days to review a standard device registration submission. The full process — from initial UKRP appointment to receiving the Registration Confirmation Letter — typically takes 4–5 weeks when handled by I3CGlobal, depending on documentation completeness and device complexity.
What is the UK MHRA Registration fee in 2025?
The current MHRA government registration fee is £261 per application, effective from 16 July 2025. This covers up to 100 device families per application. A proposed annual fee structure of £300 per GMDN Level 2 code is expected under the 2026 UKCA transition. This fee is paid directly to the MHRA via DORS and is separate from UKRP service fees.
Do CE-marked devices still need MHRA Registration?
Yes. CE Marking and MHRA Registration are separate requirements. Even if your device carries a valid CE Mark (accepted as transitional conformity evidence in Great Britain), it must still be registered via MHRA DORS before being placed on the UK market. CE Marking alone is not sufficient for legal sale in Great Britain.
What happens if MHRA Registration is not renewed?
If registration is not renewed by the deadline, the MHRA removes your records from the database. You lose the legal right to place your device on the UK market. A completely new registration application (with fees) must be submitted before sales can resume. I3CGlobal manages renewal reminders and submissions as part of our ongoing UKRP service.
Is I3CGlobal accredited by the MHRA?
UKRP service providers are not formally accredited by the MHRA — no such accreditation scheme exists. However, I3CGlobal is a registered business establishment in the United Kingdom, is listed on the MHRA DORS system as an active UKRP, and represents manufacturers across multiple countries. You can verify our UKRP status at i3cglobal.uk/verify-ukrp-and-mhra-registration-status/
Does MHRA Registration apply to custom-made devices and IVDs?
Yes. Custom-made devices must be registered with the MHRA before market placement. The registration process follows the same DORS procedure, with a Custom-Made Statement submitted as the conformity evidence. Custom-made devices that were certified under the EU MDD or EU AIMDD and placed on the EU market before 26 May 2021 may still be registered for the Northern Ireland market under specific transitional rules.
What is the MHRA DORS system?
DORS stands for Device Online Registration System — the MHRA’s online portal for submitting and managing medical device and IVD registrations in Great Britain. All registrations, renewals and updates are processed through DORS. Foreign manufacturers cannot access DORS directly; their designated UKRP creates and manages the account on their behalf.
Page updated on 19th May 2026 by Sara Moly and approved by Luke Fernandez