7. How MHRA regulates and registers medical devices

Last Updated on 23/08/2023 by Sarah Sarsby

The 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 over 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 (ABs) 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 – Register Medical Devices to Place on the Market: This guidance sets out how to register medical devices with MHRA for markets in GB and NI; 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 below for more on UKRPs);

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 Great Britain market.

NB – Procedure Packs: It is possible under UK and EU legislation^[1] 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; again, the CE/UKCA mark only applies to medical devices, and kits/packs may contain non-medical device products.

Information Required When Registering Your Devices With the MHRA

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 Respons i ble Person Guidance)

For each Device, required details include:

Applicable legislation[2]
Class of device being registered
Global Medical Devices Nomenclature (GMDN) code and term to describe the device; if unsure of the GMD N 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)

IVDs Undergoing Performance Evaluation

Coronavirus Test Device Approval (CTDA) and Registering with MHRA

In particular, see MHRA Guidance for Industry and Manufacturers: COVID-19 Tests and Testing Kits and underlying legislation at The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (No. 910).

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[3]

A statutory fee of £240 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 £100 statutory fee is applicable.

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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