6. How MHRA regulates and registers medical devices

Last Updated on 06/11/2025 by Sarah Sarsby

MHRA is the UK regulator for medical devices. It performs market surveillance of medical devices on the UK market and is able to take a decision regarding the marketing and supplying of a device in the UK. MHRA are also responsible for the designation and monitoring of UK conformity assessment bodies. For medical devices, these approved bodies are organisations that have been designated by MHRA to assess whether manufacturers and their medical devices meet the requirements set out in relevant UK medical device regulations.

MHRA – Regulating Medical Devices in the UK

This guidance sets out what is required to place a medical device on the GB, NI, and EU markets, and what MHRA does within each of these processes. This is the best overview from which to understand the medical device regulatory landscape, with sub-sections on:

MHRA – Post market Surveillance

In addition to the above guidance, MHRA has published a collection of guidance which covers post marketing surveillance information for manufacturers placing products on the GB market. This collection provides guidance on the measures that came into force on 16 June 2025, related to the SI laid in 2024 – The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. While these provisions are similar in intent to EU PMS requirements, there are important differences in scope and implementation. Manufacturers therefore need to ensure that their systems and documentation meet the specific UK requirements in addition to EU obligations, as compliance with one framework does not automatically demonstrate compliance with the other. The collection includes:

The main changes introduced by the amended PMS legislation include:

Detail on what must be included as part of a PMS system, including the methods for collecting PMS data to support improved capturing of PMS data and harmonisation across manufacturers;
Enhanced serious incident reporting obligations for manufacturers to support the detection of safety issues sooner;
Clearer obligations on manufacturers to consider conducting a field safety corrective action (FSCA) to prevent or reduce the risk of a further serious incident, accompanied by detailed requirements relating to field safety notices (FSN) to better target patients and users at risk;
More stringent requirements for manufacturers to conduct periodic reviews of their PMS data, including for implantable medical devices – this aims to support manufacturers in earlier detection of trends/signals that may have an impact on the safety of a medical device.

MHRA – Register Medical Devices to Place on the Market

Before a device can be placed on the market in the UK it must be registered with the MHRA. This guidance sets out how to register medical devices with MHRA for devices intended for the GB and NI markets. This is the best overview from which to understand the medical device registration journey with MHRA, with links to different parts of the process, including:

Who Must Register
- Manufacturers (UK-based): If based in the UK, it is the responsibility of the manufacturer to register directly with MHRA each medical device prior to placing those devices on the market.
- Manufacturers (non-UK-based) via UK Responsible Person (UKRP): If based outside the UK, it is the responsibility of the manufacturer to engage a UK-based UKRP to assume the responsibilities of the manufacturer in terms of registering medical devices with MHRA (see Section 10).
- Suppliers & Distributors (UK-based): Suppliers and distributors are not required to register with MHRA, but they are responsible for ensuring that any medical devices they do supply or distribute have been properly registered, conformity-assessed, and labelled according to all applicable UK law and regulations. In addition, if a Supplier or Distributor acts as a UKRP, they must carry out all responsibilities of a UKRP.
- Importers (UK-based): Importers are not required to register with MHRA, but in cases where an Importer is not acting as the UKRP for a device, the Importer must inform the relevant Manufacturer or UKRP of their intention to import a device, and the Manufacturer or UKRP must – in turn – provide MHRA with the Importer’s details, including their UK place of business; in cases where an Importer acts as a UKRP, they must carry out all responsibilities of a UKRP.

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When You Must Register

All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with MHRA before they can be placed on the GB market. A registration fee is required, more information on registration fees can be found in Section 2.

It is possible under UK and EU legislation [4] to combine medical devices together into a procedure pack. In the retail sector, this is most commonly seen in first aid kits, but it is not limited to this application. It is atypical to see the kit/pack as a whole CE/UKCA marked (indeed it is prohibited to do so except in some limited and rare circumstances), but any individual medical device product contained in the kit/pack should be CE/UKCA marked. It is therefore necessary to verify each individual component within a kit/pack for compliance. The CE/UKCA mark only applies to medical devices, and kits/packs may contain non-medical device products.

A full list of registration information – Organisation Details (mandatory); Importer Details (if applicable); General Device Details (mandatory); IVD Details (if applicable) – is available from MHRA as an Excel spreadsheet at Manufacturer and Device and Product and Importer Attributes.

For each manufacturer, required details include:

Legal entity name and address as it appears on the device labelling/packaging
Company type (e.g. limited company, sole trader)
Administrative contact (up to 15 people may have access)
Where applicable, a letter of designation for UK Responsible Persons (UKRPs); this must be a legal contract, stating exclusive UKRP action on behalf of the manufacturer and specifying mandatory tasks the UKRP is contracted to undertake on behalf of the manufacturer (mandatory tasks that must appear in the UKRP designation contract can be found in MHRA’s UK Responsible Person Guidance)

For each device, required details include:

Applicable legislation [4]
Class of device being registered
Global Medical Devices Nomenclature (GMDN) code and term to describe the device – if unsure of the GMDN code required, the relevant term may be selected from a drop-down list in MHRA’s registration system. Membership of the GMDN Agency is not required to find and select the appropriate GMDN term in MHRA’s system
Basic UDI-DI (if applicable)
Medical device name (brand/trade/proprietary name)
Model or version detail
Catalogue/reference number
UDI-DI (if applicable)
UK Approved Body or EU Notified Body (if applicable)
Device attributes (e.g. sterility, contains latex, MRI-compatible, etc.)
A copy of any conformity assessment certificate or self-certification conformity declaration (as applicable)

Further guidance is provided for the registration of reusable or unclassified (those devices whose classification will change to a higher risk classification on implementation of the EU MDR) and/or devices relying on expiring CE certificates can be found here:

* ‘up-classified’ refers to a situation where a device that was placed in a lower risk class under the Medical Devices Directive (MDD 93/42/EEC) is now placed in a higher risk class under the Medical Devices Regulation (MDR (EU) 2017/745)) as a result of stricter MDR classification rules.

Apply to Register on the Device Online Registration System (DORS)

A Manufacturer or UKRP must create an account on MHRA DORS before beginning to register medical devices with MHRA.

MHRA will email account applicants to confirm whether any account request has been accepted or rejected.

NB: You will not be regarded as registered with MHRA until you have provided detailed information required at registration. Before placing devices on the market, you must ensure all information registered with MHRA is accurate and up to date; MHRA may request additional technical documentation from you to demonstrate your products conform to the relevant regulatory requirements before your registration is confirmed.

To set up an account:

Click on MHRA – Register Medical Devices to Place on the Market;
Scroll approximately 2/3 of the way down the page, to a section headed “Apply to register on the Device Online Registration System (DORS)”;
Click on the MHRA DORS link in this section; this will take you to a new MHRA window where you fill out a form to request an MHRA DORS account;
Once you receive your account details from MHRA – which will follow via email after you’ve carried out the step above – log into your DORS account, complete your registration, and begin registering your devices (see sub-section immediately above for Manufacturer/Device information required for registration);
Finally, at the bottom of the MHRA – Register Medical Devices to Place on the Market page are links to MHRA’s full instruction manuals on: creating & managing your DORS account (Account Management Reference Guide) and registering individual devices (Device Registration Reference Guide); as well, there is a list of video-tutorials that take you screen-by-screen through the DORS system.

MHRA Fees

A statutory fee of £261 applies for each registration application.

Registrants can register up to 100 devices (GMDN) with a cumulative maximum of 20,000 products (UDI-DI, medical device name, model or version, catalogue/reference detail) within each application.

If registrants need to update any information within an existing registration, a statutory fee is applicable.

Following the MHRA consultation on statutory fees – proposals on ongoing cost recovery, and extensive stakeholder feedback, the government has revised its approach to medical device fees.

The previously proposed £210-per-GMDN annual fee will be replaced with a new £300 annual fee, applicable per GMDN Level 2 category (or Level 1 where Level 2 does not exist). This new fee structure will replace the current one-off £261 registration fee and will come into effect on 1 April 2026, instead of April 2025 as originally planned. The change aims to support post-market surveillance (PMS) activities. Approximately 60% of manufacturers are expected to pay only a single charge. All fees will continue to be paid via DORS. More information can be found within the government response to the consultation.

Until the new fee structure comes into effect on 1 April 2026, the statutory fee of £261 applies for each registration application applies.

Review Registration

MHRA encourages regular review of device registrations and sets out here their program of review notification within the DORS system.

Making Changes to Your Registration

MHRA sets out here which changes to device registration – including address, company name, additional devices, change of UKRP – are chargeable.

Registration of Certain Medical Devices That Have Expired/Expiring CE Certificates

Please see Sections 3 & 4 above for details of EU revision of EU MDD-to-EU MDR transitional arrangements, steps required to rely on an expired CE certificate that has been deemed valid under EU MDR, and Transition Date Matrix.

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