The MHRA medical device registration framework changed significantly on 1 April 2026. A new annual fee structure replaced the previous one-off registration charge. The Device Online Registration System (DORS) moved to a continuous maintenance model. And the role of the UK Responsible Person (UKRP) became more operationally demanding. For distributors placing medical devices on the UK market, these changes affect compliance timelines, annual budgets, and the consequences of non-payment.
This guide covers every material change to MHRA medical device registration in 2026, what distributors and manufacturers must do to remain compliant, and what happens if registration obligations are missed.
What changed in MHRA medical device registration on 1 April 2026
Three changes took effect simultaneously on 1 April 2026. Each one requires a different operational response.
The one-off fee is gone. Annual fees are now in place.
Until 31 March 2026, the MHRA charged a one-off registration fee of £261 per registered device category. A new fee structure came into effect on 1 April 2026. It has replaced the previous one-off registration fee regime. Manufacturers are now charged annually based on how many Level 2 GMDN categories their devices are registered under.
The MHRA has indicated an estimated amount of £300 per GMDN Level 2 category from 1 April 2026, and has noted that approximately 60 percent of manufacturers are expected to pay a single charge. For manufacturers with a single video laryngoscope system registered under one GMDN category, the annual cost is approximately £300. Manufacturers with broader portfolios spanning multiple device categories pay per category, not per individual device or SKU.
Pro-rata charges apply for new devices added mid-year. Annual fees are estimated at around £300 per GMDN category. If a new device category is added in October, the fee for that category is calculated based on the number of days remaining in the annual billing cycle.
The DORS “Renew Registration” function has been removed
Under the old system, manufacturers renewed registrations periodically through a specific renewal workflow in DORS. The “Renew Registration” function has been removed from April 1, 2026, and continuous account maintenance is now required for accurate fee calculation.
This means manufacturers and UKRPs can no longer treat registration as a periodic task. They must maintain accurate DORS records continuously throughout the year. GMDN codes, UDI data, product details, and company information must stay current at all times.
After April 2026, updates to the company name, address, and contact information will no longer incur a fee. Administrative changes are now free. Product and category changes may still carry charges depending on the nature of the update.
Non-payment consequences are severe
Annual invoices must be paid within 90 days. Non-payment leads to account suspension and removal from the Public Access Registration Database (PARD). Suspended accounts cannot place devices on the UK market or request Certificates of Free Sale.
This is a harder consequence than most manufacturers and distributors have previously faced under the one-off fee model. A suspended registration means the device cannot legally be sold in Great Britain until the account is reinstated. For distributors carrying stock of a device whose manufacturer has a suspended registration, this creates direct commercial and legal exposure.
How MHRA fees are calculated under the new model
Understanding the fee calculation prevents overpayment and avoids compliance gaps. The BHTA’s summary of the MHRA updated response lays out the mechanics clearly.
The fee is based on GMDN Level 2 categories, not individual devices. A manufacturer with one video laryngoscope model and three blade variants registered under the same GMDN Level 2 category pays one fee of approximately £300. A manufacturer with both a video laryngoscope and a traditional laryngoscope registered under two separate GMDN Level 2 categories pays approximately £600.
The fee was modelled at GMDN category level 2, rather than level 5, which is a higher, more general level. This results in costs being more equitably spread across manufacturers.
The MHRA calculates fees based on a snapshot of registered categories on 1 April each year. Manufacturers should review their DORS registration entries before 1 April to ensure obsolete or inactive devices are removed. Removing a redundant GMDN category before the snapshot date eliminates the annual fee for that category going forward.
Payments are accepted through WorldPay, BACS, or CHAPS via DORS only. Payments outside DORS are not accepted. Manufacturers paying by BACS or CHAPS must include the unique reference number provided in DORS as the reference in their bank payment portal. Missing this reference causes payment identification delays and risks account suspension even when payment has been made.
What the DORS data cleansing deadline meant for manufacturers
Before the new fee model went live, the MHRA ran a data cleansing window. The DORS system went offline for transition until April 1, 2026, with a final submission deadline of 5:00 pm on 30 March 2026 for draft entries.
Manufacturers who missed the data cleansing window before 30 March 2026 may now carry unnecessary GMDN categories in their DORS account. Each of these generates an annual fee charge. The practical fix is to audit DORS entries now, identify any obsolete or inactive device registrations, and remove them through the standard DORS update process. The MHRA has been contacting some manufacturers regarding outdated pseudo GMDN codes that remain on their registration accounts. These codes were applied automatically when accounts were migrated to a new MHRA registration system several years ago. Under current UK medical device regulations, these temporary codes are no longer acceptable.
If a DORS account was suspended before 30 March 2026, that account cannot be reactivated through the standard renewal pathway. A new account must be created.
What the UK Responsible Person (UKRP) must do under the 2026 framework
For manufacturers based outside the United Kingdom, the UKRP carries the registration obligations in DORS. This role has become more operationally significant under the 2026 changes.
Before any device is placed on the market, the UKRP must register with the MHRA via the DORS database, providing written evidence of their authority to act on the manufacturer’s behalf.
Since Brexit, appointing a UK Responsible Person has become a core requirement for most non-UK medical device manufacturers entering the Great Britain market. The role looks familiar but its obligations under the UK MDR 2002 are distinct, legally binding, and far more visible to the MHRA. For manufacturers without a UK presence, the UKRP is not optional. It is the regulatory backbone ensuring that devices are correctly registered, technically compliant, traceable, and monitored post-market.
Under the 2026 fee model, the UKRP is responsible for:
Paying annual registration fees on behalf of represented manufacturers through DORS. Maintaining accurate GMDN category registrations year-round. Removing obsolete device entries before the 1 April snapshot date to avoid unnecessary fees. Ensuring payment reaches MHRA within 90 days of invoicing. Updating Letters of Designation when manufacturer relationships change.
The MHRA has proposed significant regulatory changes for 2026 and 2027 that will expand the UKRP role to align more closely with the EU Authorised Representative under MDR and IVDR. Proposed changes include requiring the UKRP to appoint a Quality Person analogous to a Person Responsible for Regulatory Compliance under the MDR and IVDR, and establishing UKRP product liability for the manufacturer’s defective devices.
For distributors evaluating a manufacturer’s UK market readiness, confirming that the manufacturer has an active, compliant UKRP in place is now as important as confirming the device registration itself.
How MHRA registration differs from FDA and Health Canada pathways
Distributors operating across the U.S., Canada, and UK face three different registration frameworks. The MHRA 2026 model has several features that distinguish it from its counterparts.
No product-level licence equivalent to Health Canada’s MDL. The MHRA registers devices by GMDN category, not by individual product licence. A manufacturer with MHRA registration under the relevant GMDN category can place any device within that category on the UK market without a separate per-device approval process.
No submission equivalence to FDA 510(k). The MHRA does not require a premarket notification equivalent for CE-marked Class IIa devices entering the UK under the current recognition framework. Registration in DORS under the correct GMDN category, combined with an active UKRP, is the primary market access requirement.
Annual cost model versus per-application fees. Both the FDA establishment registration fee ($7,653 annually) and the Health Canada MDEL ($5,426 annually) charge on a per-establishment basis. The MHRA’s new model charges per GMDN category, which means manufacturers with narrow portfolios pay less while those with diverse device portfolios pay proportionally more.
For a full comparison of the Health Canada registration pathway, see our guide on medical device registration in Canada: a distributor’s walkthrough. For the CE marking and UKCA implications that sit alongside the MHRA registration process, see our guide on CE marking, UKCA, and MHRA recognition.
What should distributors do right now?
The 2026 MHRA changes have already taken effect. The following steps keep distributors and their manufacturer partners on the right side of the new framework.
Step 1: Confirm manufacturer DORS registration status. Search the MHRA Public Access Registration Database to confirm the manufacturer’s registration is active. A suspended registration means you cannot legally distribute the device in Great Britain.
Step 2: Confirm UKRP appointment is current. Ask the manufacturer for the name and contact details of their appointed UKRP. Confirm the UKRP’s Letter of Designation is current and filed in DORS. A UKRP whose account was not updated before 30 March 2026 may have had their account suspended or closed.
Step 3: Understand your own registration obligations. Distributors and other suppliers that do not import devices for placement on the Great Britain market are not required to be registered with the MHRA. However, if you are an importer bringing devices into Great Britain from outside the UK, you carry separate importer obligations under the UK MDR 2002. Confirm which role your business performs and whether MHRA registration applies to you directly.
Step 4: Budget for annual fees. If you are represented as a manufacturer or act as a UKRP for manufacturers, build the annual MHRA fee cycle into your compliance budget. Approximately £300 per GMDN Level 2 category, due within 90 days of 1 April each year.
Step 5: Audit DORS entries for obsolete registrations. Any inactive or obsolete GMDN categories left in a manufacturer’s DORS account generate annual fee charges. Review entries now and remove redundant categories before the next 1 April snapshot.
Astra-vue’s video laryngoscope systems are CE marked and supported by a compliant UK regulatory structure. For information on UK market access, UKRP arrangements, and distributor support, contact our team or explore the full product line.
Frequently asked questions about MHRA medical device registration in 2026
What is the new MHRA annual fee for medical device registration?
From 1 April 2026, a recurring annual fee replaces the one-off fee. It is based on the number of chargeable GMDN Level 2 categories under which a manufacturer has registered products, with an estimated cost of approximately £300 per category. Approximately 60 percent of manufacturers are expected to pay a single annual fee of £300.
What happens if a manufacturer does not pay the MHRA annual fee?
Non-payment leads to account suspension and removal from the Public Access Registration Database. Suspended accounts cannot place devices on the UK market or request Certificates of Free Sale. This means distributors carrying that manufacturer’s devices face an immediate legal barrier to sales in Great Britain.
Do distributors need to register with the MHRA?
Distributors and other suppliers that do not import devices for placement on the Great Britain market are not required to be registered with the MHRA. However, importers who bring devices into Great Britain from outside the UK have separate obligations under the UK MDR 2002. The key distinction is between a distributor receiving goods already imported into Great Britain versus an importer who is the first to bring goods across the UK border.
Is a UK Responsible Person required for all non-UK manufacturers?
Yes for most non-UK manufacturers placing devices on the Great Britain market. Following Brexit, medical device and IVD manufacturers without a UK registered office must appoint a UK Responsible Person to place devices on the Great Britain market covering England, Scotland, and Wales. Northern Ireland operates under the Windsor Framework and has separate requirements.
What is a GMDN Level 2 category and how does it affect registration fees?
GMDN stands for Global Medical Device Nomenclature. It is an international classification system for medical devices. Level 2 is a mid-level grouping that covers a broad device type without going to individual product specificity. The MHRA uses Level 2 as the fee basis because it distributes costs more equitably than charging per individual device while still reflecting the scope of a manufacturer’s product range.
