MHRA registration for medical devices: who registers, how and the fee

MHRA registration is how a manufacturer tells the Medicines and Healthcare products Regulatory Agency (MHRA) that a medical device or in vitro diagnostic (IVD) is going on the market, and it is done online in the Device Online Registration System (DORS). Since 1 April 2026 it costs £300 a year for each Level 2 category of the Global Medical Device Nomenclature (GMDN) you register, which is not the flat fee older guides still quote.

Here we walk through who has to register, how DORS works, the fee and where it came from, the information you need before you start, the UK Responsible Person requirement for manufacturers outside the UK, what changed for Northern Ireland in May 2026, how long CE marked devices are accepted in Great Britain, and how to search the public MHRA database.

Who has to register with the MHRA?

The MHRA medical devices guidance casts a wider net than the word “manufacturer” suggests. You must register if you sell, lease, lend or gift any of the following:

• Class I, IIa, IIb or III devices you manufactured.
• Devices you refurbished or relabelled with your own name.
• Any system or procedure pack containing at least one medical device.
• Custom made devices.
• IVDs you manufactured.
• IVDs undergoing performance evaluation.

Two points catch people out. “Gift” is on the list, so free samples and donated stock are not outside the rule. And the mark does not change the answer. A CE marked device placed on the Great Britain market is registered in the same system as a UKCA (UK Conformity Assessed) marked one, which is why DORS asks whether a UK Approved Body or an EU Notified Body was involved.

How do you register a medical device with the MHRA?

MHRA device registration happens in DORS and nowhere else. The MHRA is precise about the moment it counts: you are not regarded as registered until you have provided details of the device and received confirmation. Opening an account is not a registration. The confirmation is.

DORS asks for information at two levels. For the organisation:

• The legal entity name and address, exactly as they appear on the label.
• The company type.
• Up to 15 administrative contacts.
• For a UK Responsible Person, the letter of designation.

For each device:

• The legislation it is placed under and its class.
• The GMDN code and term.
• The Basic UDI-DI, the database key of the Unique Device Identification (UDI) system, if applicable.
• Brand name, model and catalogue number.
• The UK Approved Body or EU Notified Body.
• The certificates or declarations of conformity.

The form is rarely the problem. The inputs are. An address that does not match the label. A class worked out under the EU rules, when Great Britain still classifies general devices under Annex IX of Directive 93/42/EEC. A certificate that has expired. The MHRA’s Public Access Registration Database (PARD) flags such devices as “Conformity Assessment Certificate Expired”, and they cannot be registered or placed on the market as new stock. Settle the technical file and the label first, then register.

Fees are paid through DORS only. If you pay by bank transfer (BACS or CHAPS), quote the DORS reference.

How much does MHRA registration cost in 2026?

From 1 April 2026 the fee is £300 a year per Level 2 GMDN category, or per Level 1 category where no Level 2 exists. That figure is for the 2026 to 2027 charging year, and the MHRA says the fee will change annually, so check the current rate before you budget. Several GMDN terms that sit under the same Level 2 category are charged once a year for that category, not once per term. The charging period runs from 1 April to 31 March, and a registration made part way through is charged pro rata.

The legal basis is the Medical Devices (Fees Amendment) Regulations 2026, SI 2026/197, made and laid on 25 February 2026. Regulation 3 replaces “£261” with “£300” and defines a registration category as a GMDN Level 2 category, or Level 1 where no Level 2 applies. Regulation 4 makes the same provision for Northern Ireland.

Date	What changed	Fee
16 July 2025	Statutory registration fee increased	£261
1 April 2026	New annual fee structure under SI 2026/197, and the Renew Registration function removed	£300 a year per Level 2 GMDN category
1 April 2026 to 31 March 2027	Current charging period	£300 per category, pro rata for registrations made mid period

Not everything is charged. There is no fee for updating an address, uploading conformity documents or removing discontinued products. The fee applies when you add devices in a new GMDN category, or when a change needs re registration.

Because the fee follows the category, a broad GMDN term looks cheaper. Resist that. Choose the term that describes the device, then work out what it costs. Our guide to choosing GMDN codes explains why a term picked for price causes trouble later.

Do you need a UK Responsible Person to register?

If you are based outside the UK, yes. Regulation 7A(2)(a)(ii) of the UK Medical Devices Regulations 2002 requires a manufacturer based outside the United Kingdom to appoint a sole UK Responsible Person, who gives the Secretary of State written evidence of its authority to act.

In DORS that evidence is the letter of designation. The MHRA describes it as a legal contract stating that you are the exclusive UK Responsible Person.

The role carries eight statutory tasks under regulation 7A(3). The UK Responsible Person must make sure the declaration of conformity and technical documentation are drawn up and, where applicable, that conformity assessment has been carried out. It keeps those documents and the certificates available for inspection, supplies information, samples or access when asked, and passes requests on to the manufacturer. It cooperates on preventive or corrective action and tells the manufacturer immediately about complaints and incident reports. If the manufacturer breaches its obligations, it terminates the relationship and informs the Secretary of State and the Approved Body.

Where the UKCA mark is affixed, including on devices that carry both the CE and UKCA marks, the UK Responsible Person’s name and address go on the labelling, the outer packaging or the instructions for use. CE marked only devices do not need them. Our complete guide to the UK Responsible Person covers the appointment in more depth.

Can CE marked devices still be sold in Great Britain?

Yes, within fixed dates, and they still have to be registered. The table sets out current law for devices under the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD), the In Vitro Diagnostic Medical Devices Directive (IVDD), the EU Medical Device Regulation (EU MDR) and the EU In Vitro Diagnostic Regulation (EU IVDR).

CE marked under	Accepted in Great Britain until
MDD or AIMDD, certified by a Notified Body	The sooner of certificate expiry or 30 June 2028
IVDD	The sooner of certificate expiry or 30 June 2030
EU MDR, including custom made devices	30 June 2030
EU IVDR	30 June 2030

The MHRA adds one exception to the directive dates: they do not apply to Class I devices and general IVDs where neither the directive nor the EU MDR or IVDR requires a Notified Body. For those self declared devices the question is whether they meet the EU MDR or IVDR, so check which group your device falls into before relying on 2028.

The government consulted from 16 February to 10 April 2026 on extending the MDD arrangements and on recognising EU MDR and EU IVDR devices indefinitely. No outcome has been published. Plan on the dates in the table. Our guide to UKCA marking in 2026 covers what that means for your choice of mark, and our guide to the UK Medical Devices Regulations 2002 covers the reforms still in draft.

What changed for Northern Ireland on 28 May 2026?

Northern Ireland follows the EU rules. The EU MDR has applied there since 26 May 2021 and the EU IVDR since 26 May 2022. CE marking is required, and the MHRA is the competent authority. A Great Britain manufacturer supplying Northern Ireland must designate a sole authorised representative based in the EU or Northern Ireland. Where a UK notified body carries out the conformity assessment, the device needs a combined CE and UK(NI) mark.

Registration has moved. Since 28 May 2026, every device placed on the Northern Ireland market, other than custom made devices, must be registered on EUDAMED, the European database on medical devices. Custom made devices are still registered with the MHRA, within 28 days of being made available on the Northern Ireland market. If your plan for Northern Ireland still says “register with the MHRA”, it is out of date. Our EUDAMED guide sets out how that database works.

How do you check the MHRA database?

The public MHRA register is PARD, at pard.mhra.gov.uk. A manufacturer’s record shows its name and address, its MHRA reference number, the registered device types by GMDN term and five digit code, and brand or trade names. Where there is a UK Responsible Person or Northern Ireland authorised representative, those details sit inside the manufacturer’s record.

Know its limits before you rely on it:

• You cannot search PARD by representative. The MHRA says so directly. To confirm who acts for a manufacturer, you find the manufacturer first.
• IVDs registered for performance evaluation are not published.
• Northern Ireland devices other than custom made ones are now registered on EUDAMED, so PARD is not the place to check them.
• A listing is not an approval. The MHRA states that registration does not represent any form of accreditation, certification, approval or endorsement. MHRA logos and claims of that kind must not appear in marketing or on packaging.

If you are a distributor checking a supplier, PARD tells you a registration exists. It does not tell you the device is compliant.

Where manufacturers go wrong with MHRA registration

Most of these come from advice that was right a year or two ago.

• “It costs £261 per application.” Not since 1 April 2026. It is £300 a year per Level 2 GMDN category.
• “Register once and it is done.” The fee is now an annual charge.
• “Being on PARD means the MHRA approved the device.” The MHRA says the opposite in terms.
• “Northern Ireland devices still go to the MHRA.” Since 28 May 2026 they go on EUDAMED, apart from custom made devices.
• “We can find our competitors’ UK Responsible Person on PARD.” You cannot search by representative.

Where Worldwide Device Solutions fits

We act as UK Responsible Person from Newcastle upon Tyne and EU Authorised Representative from Cork, on one contract. MHRA medical device registration is part of our UK Responsible Person service: the letter of designation, the GMDN categories, and a check that the address, class and certificates in DORS match your label and technical file. Behind it sits 27+ years in global QA and RA (quality assurance and regulatory affairs).

If you are not sure your current registration or fee position is right, book a free consultation and Paul will go through it with you. If the question is wider readiness for Great Britain, the fixed fee Gap Assessment is the quicker route.