Register medical devices to place on the market

All medical devices, including in vitro devices (IVDs), custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in Great Britain (England, Wales and Scotland).

In Great Britain devices must conform to the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that they can be placed on the market and registered with the MHRA.

Registration requirements differ for Northern Ireland.

The MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that are based in the UK, or from Authorised Representatives based in Northern Ireland (for the purposes of the Northern Ireland market).

You must ensure all information registered with the MHRA is accurate and up to date.

Registration of your devices with the MHRA (the UK competent authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA.

Therefore, you are not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions for use, on laboratory tickets/dockets, or in any other documentation.

If you are registering a Coronavirus (COVID-19) test kit with the MHRA, take note of our guidance for industry and manufacturers.

As part of our data validation and scrutiny of applications to register medical devices and products with the MHRA, we may request further technical documentation from you that demonstrates your products conform to the requirements of the Medical Device Regulations.

WhoRegistration mustfor registerthe Great Britain Market

The following requirements apply to place your device on the UK market.

Placing a device on the Great Britain market

market.

It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your device on the market in Great Britain.

You must register if you or your company sells, leases, lends or gifts:

• Class I, IIa, IIb or III devices you have manufactured
• Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name
• any system or procedure pack containing at least one medical device
• custom-made devices
• IVDs you have manufactured
• IVDs undergoing performance evaluation

Register your device to place on the Great Britain market

If the manufacturer is based outside the UK, they must appoint a single UK Responsible Person to take responsibility for all of their medical devices.

Please note that the accounts of any former Great Britain-based Authorised Representatives that have not updated their role to UK Responsible Person on the MHRA registration system, as well as the accounts of any represented manufacturers, have been suspended since 1 January 2022 until the UK Responsible Person has updated their role.

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Information required when registering your devices with the MHRA

ProvideWhen registering devices with the followingMHRA, informationyou whenmust registeringprovide yourthe devicesinformation withlisted us.below. These lists are non-exhaustivenon-exhaustive, and we may request further technical documentation from you as part of our scrutiny and data validation process.

Manufacturer details:

• legal entity name and address as it appears on the device labelling/packaging
• company type (for example, limited company, sole trader)
• administrative contact (you can have up to 15 people with access)
• a letter of designation for UK Responsible Persons (where applicable)

The letter of designation for UK Responsible Persons must be a legal contract, stating that you are the exclusive UK Responsible Person acting for the manufacturer and specifying the mandatory tasks you are contracted to undertake on behalf of the manufacturer. The mandatory tasks that must appear in the designation contract can be found in our our regulatory guidance for UK Responsible Persons.

A written mandate from the manufacturer must be submitted by the manufacturer or the Northern Ireland Authorised representative (where appointed) for registrations for the Northern Ireland market. The mandate must meet the requirements of the EU MDR 2017/745 and/or EU IVDR 2017/746.

Device details:

• which legislation applies
• the class of device you are registering - if you are unsure of the classification and particularly if you are registering with a self-certification conformity declaration, see see Borderline products: how to tell if your product is a medical device
• Global Medical Devices Nomenclature ( (GMDN)® Code and Term to describe your device
• basic basic UDI-DI (if (if applicable)
• medical device name (brand/trade/proprietary name)
• model or version detail
• catalogue/reference number
• UDI-DI (if (if applicable)
• UK Approved Body (or EU Notified Body) where applicable
• attributes such as sterility, contains latex, MRI compatible

You also need to provide a copy of any conformity assessment certificates or self-certification conformity declarations, as applicable.

If you do not know which GMDN® Code applies to your device, you will be able to select the relevant Term from our system. You do not need to be a member of the GMDN® Agency to find and select the appropriate GMDN® Terms in our online registration system (DORS).

However, please note that GMDN® is a worldwide system and not all of its codes and terms are considered to be medical devices in the UK. For further guidance on whether certain products are medical devices in the UK, see see Borderline products: how to tell if your product is a medical device.

For a full view of the fields required, refer to the the Manufacturer and device and product and importer attributes list.list.

Custom-made devices

There is further information about about custom-made devices. This This includes examples of the information we need.

If you are submitting a registration for a custom-made active implantable device, provide us with a copy of the instructions for use and the device labelling.

Custom-made devices under the EU EU MDD or or EU EU AIMDD can can no longer be placed on the GBGreat orBritain NIor Northern market.Ireland market. Note that you can register your custom-made device under UK MDR 2002 Part II or Part III (which is currently consistent with EU EU MDD or or EU EU AIMDD requirements) requirements) for the GBGreat Britain market only, with a suitable accompanying custom-made statement.

Contact the MHRA by emailing Device.Registrations@mhra.gov.uk for advice on how to register your custom-made devices if:

• you are a manufacturer based outside the UK, and
• you do not have a Northern Ireland-based Authorised Representative, and
• you wish to place custom-made devices on the Northern Ireland market only

Only custom-made devices consistentthat comply with EU MDR 2017/745 can be placed on the Northern Ireland market.

Custom-made devices registeredthat undercomply with the EU EU MDD or or EU EU AIMDD and andwere placed on the market in an EU member statestate, other than Northern Ireland, prior to 26 May 2021, can still be registered with MHRA for the purposes of placing on thethe Northern NIIreland market market only.

Systems and procedure packs

Systems and procedure packs are covered by the registration requirements set out above. You need to register if your company places on the market a system or procedure pack under your own name, and within the intended purposes and limits specified by the manufacturer, which contains devices bearing any of the following marks:

• UKCA
• CE
• CE UKNI

You need to register if your company sterilises, to place on the market under your own name, a system or procedure pack which contains devices bearing any of the following marks:

• UKCA
• CE
• CE UKNI

This is applicable to devices that are intended by the manufacturer to be sterilised before use. Manufacturers of systems and procedure packs must:

• register each system or procedure pack using GMDN
• add at least one underlying product

upload a list of all the possible components that might be included in the system or procedure packs for that GMDN

.

IVDs undergoing performance evaluation

IVDs subject to new performance evaluation studies in the UK must be registered by the manufacturer, UKRP or Northern Ireland Authorised representative by the time the study commences.commences.  

IVDs that are subject to existing ongoing performance evaluations (commenced before 31 December 2020) must also be registered.registered by the relevant person. 

Non-UK manufacturers placing devices on the market for performance evaluation studies in Great Britain will require a UK Responsible Person in order to register with us.

For all performance evaluation studies, we require a Declaration for Performance Evaluation – to UK MDR 2002 Regulation 43 Statement, Annex VIII of Directive 98/79/EC, or Part A of Annex XIII of EU regulation 2017/746.

Coronavirus test device approval (CTDA) and registering with MHRA

Under regulation 34A of the Medical Devices Regulations 2002 no antigen or molecular detection COVID-19 (SARS-CoV-2) test may be placed on the UKUK market market without first being validated against minimum performance standards through a coronavirus test device approvals desktop review. PersonsManufacturers wishing to supply, put into service or placedistributors onsupplying theCOVID-19 UKtests marketmust a coronavirus test device, need to apply toto MHRA theas UK’sset Healthout Securityin Agencythis (UKHSA) for approval.guidance.

Registration applications for covid test devices will not be accepted by the MHRA until the devices have received CTDA or are placed onto the temporary protocol list. If you believe your Covid test device is exempt from the approval requirements and wish to register it with MHRA, it is probable you willmay be contacted to specify the exemption applicable under the Medical Devices Regulations 2002 (as amended by by The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 before before your MHRA registration application is accepted.accepted .

For full details see see For industry and manufacturers: COVID-19 tests and testing kits.

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

You need to create an account on the MHRA DORS before you can start registering your devices.

We will email you to confirm if your account request has been accepted or rejected.

You will not be regarded as registered with the MHRA until you have provided details of the device you are registering and have received confirmation that your device is registered. You must ensure all information registered with the MHRA is accurate and up to date. We may request additional technical documentation from you to demonstrate your products conform to the relevant regulatory requirements before your registration is confirmed.

Registration of your devices with the MHRA (the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the MHRA.

Therefore, you are not permitted to make any claims to this effect, including the use of any MHRA logos in any marketing materials, on device packaging, in the instructions for use, on laboratory tickets/dockets, or in any other documentation.

If you are registering devices as a UK Responsible Person or a Northern Ireland-based Authorised Representative, you also need to provide details of the manufacturer(s) you are representing. The above device registration process will then apply.

Fees

Fees until 31 March 2026

A statutory fee applies for each registration application.

See Current MHRA fees for further information on how fees are calculated and a link to the fees consultation response.

Ensure that payments for device registration applications are only made through the Device Online Registration System (DORS).

When paying by BACS/CHAPS, you must include the unique reference number provided on the payment page in DORS as the reference number in your bank payment portal. Failure to do so will result in delays to your application and potential suspension of your account until the payment can be identified by MHRA’s finance team.

You can register up to 100 devices (GMDN®) with a cumulative maximum of 20,000 products (medical device brand/trade/proprietary name, model/version, catalogue/reference, UDI-DI etc.) in each application.

If you need to update or change any information in an existing registration, you may be charged a statutory fee.

See making changes to your registration for details of all chargeable changes.

Fees from 1 April 2026

A new fee is planned to come into effect on 1 April 2026 and will apply for the financial year 2026-27. It will replace the current one-off registration fee regime.

Manufacturers will be charged annually based on how many Level 2 GMDN® Categories their devices are registered under. If multiple GMDN® and products are registered under the one Level 2 Category, they will only be charged once per year for that Level 2 GMDN®Category.® Category. Some products fall under more than one Level 2 GMDN® Category, and these will also only be charged once per a year.

For registrations made within the charging period, 1 April to 31 March, the annual fee will be payable for the registration on a pro rata basis.

Calculation of each manufacturer’s 2026/27 fee will be based on the Level 2 GMDN® Categories that their registrations fall under on 31 March 2026.

The estimated unit cost for the fee from 1 April 2026 will be in the region of £300 per year, per Level 2 GMDN® Category.

Please see the updated government response to the MHRA consultation on statutory fees for further information on the new fee structure.

In preparation for the new fee, it is important that customers review their registration account to ensure all data is correct.

In particular please check and update the following, as necessary:

• Registration Status of Account – if your account is currently suspended, please see Review registration
• Main Contact email address
• Organisation address
• All registered devices and products
• Remove any ‘Pseudo’ GMDN® that were migrated from our previous DORS system. These are not valid registrations and will be removed from DORS on 31 March 2026

Please see Making changes to your registration for further information on chargeable and free of charge changes.

Review registration

You should review your registration frequently to make sure it is up to date. It is a legal requirement to inform the MHRA of any changes to your registration per regulations 7A (general medical devices) and 19 (custom-made general medical devices), regulations 21A (active implantable medical devices) and 21B (custom-made active implantable medical devices), and regulations 33A (in vitro diagnostic medical devices) and 44 (in vitro diagnostic self-testing devices) of the Medical Devices Regulations (2002) (SI 2002 No 618) (as amended) concerning registration of persons placing medical devices on the Great Britain or Northern Ireland markets, as and when they occur. Please do not wait for reminder emails.

Until 30 March 2026

We have implemented a renew registration process as a reminder to review your registration and confirm that it is up to date. The first renewal date is 1 year after account request was completed by the MHRA, and then at least every 2 years. You will receive automated email reminders 3, 2 and 1 month before your renewal date – you can review and submit the renew registration application from 3 months before the renewal date. There is currently no fee for this application.

If you do not review your registration and submit the renew registration application on or before 30 March 2026, your account will be suspended. Suspended accounts are removed from the Public Access Registration Database (PARD) and you will not be able to add new devices or order certificates of free sale until you have reviewed your registration and submitted the renewal application.

Review organisation details and all registered devices and products and take the necessary action to ensure the data is correct and up to date. Follow the manage registered devices instructions in the Device registration reference guide and watch the video tutorial for steps on how to review your devices and take any necessary action. This includes uploading new conformity documents, adding or removing products, adding devices, or removing devices (that you no longer manufacture, or migrated devices with Pseudo Global Medical Device Nomenclature (GMDN®), where applicable).

Update any data fields that were not previously populated by following the update registered devices and products instructions in the Device registration reference guide and watch the video tutorial. In particular we urge you to provide the UDI-DIs for your devices (where applicable) as these will be crucial for monitoring and ensuring patient safety.

If any changes need to be made to organisation details or new devices need to be added to your registration/s these are separate transactions that incur the statutory fee per application. Note that if your organisation name and/or address has changed you must update these before renewing your registration. You cannot do this in the renew registration application. Follow the instructions for editing organisation details in the Account management reference guide. The fee is payable.

If no changes need to be made, you will not currently be charged for this review. Follow the renew registration instructions in the Account management reference guide and watch the renew registration video tutorial.

Any device registration accounts that remain suspended at 17.00 on 30 March 2026 will be closed. If you wish to place medical devices on the market on or after 1 April 2026 you will need to create a new account and register all devices again under the new fee structure.

From 1 April 2026

The Renew registration function will be removed from DORS on 1 April 2026. You will still be required to review your registration frequently to make sure it is up to date, in order to meet legislation requirements, and to enable correct calculation of fees.

Making changes to your registration

If you are already registered with the MHRA, we encourage you to make the necessary changes to your registered information as and when they occur. Do not wait for reminder emails.

Log into MHRA DORS (Device Online Registration System). This is for existing customers only.

If you registered with the MHRA before 1 July 2018 and have a registration number that begins with ‘CA, or IVD’ or your registration does not appear on the Public Access Registration Database (PARD) you will need to re-register your organisation details and devices on the DORS system.

Note that we now ask for more detailed information on your devices and products and request that you upload conformity assessment documents.

You must notify us of any changes to your registration details.

A statutory fee is chargeable until 31 March 2026 for changes to the following:

• address
• company name
• adding devices to your registration record or the registration record of manufacturers you represent
• changing device characteristics, for example, class, from non-sterile to sterile or v.v., trade/brand name, UDIs or any field that cannot be updated in DORS – the device will need to be re-registered
• changing status of an IVD, for example a change from ‘performance evaluation’ to ‘new’ - you will need to register the IVD device again
• changing the legislation of a device (for example, from MDD/AIMD/IVDD to UK MDR 2002 part II,III or VI, or to MDR/IVDR, a new registration is required
• change of role from Authorised Representative to UK Responsible Person or vice-versa (fee chargeable per represented organisation)
• change of UK Responsible Person
• adding new/additional represented manufacturers
• uploading new letter of designation for represented manufacturers

A statutory fee will be payable from 1 April 2026 for changes to the following:

• adding devices to your registration record or the registration record of manufacturers you represent, that do not fall under a Level 2 GMDN® Category that already exists on the account
• changing device characteristics, for example, incorrect GMDN® assignment, class, from non-sterile to sterile or v.v., trade/brand name, UDIs or any field that cannot be updated in DORS – the device will need to be re-registered. The fee will be payable for new Level 2 GMDN® Categories
• changing status of an IVD, for example a change from ‘performance evaluation’ to ‘new’ - you will need to register the IVD device again. No fee will be payable if the GMDN® Category of the new registration remains the same as the ‘performance evaluation’ registration
• changing the legislation of a device (for example, from MDD/AIMD/IVDD to UK MDR 2002 part II,III or VI, or to MDR/IVDR, a new registration is required. No fee will be payable if the GMDN® Category of the new registration remains the same as the existing registration under different legislation
• change of UK Responsible Person, a new registration is required
• adding new/additional represented manufacturers

You will not be charged the statutory fee for changes to the following on or after 1 April 2026:

• address
• company name
• uploading new letter of designation for represented manufacturers

You will not be charged the statutory fee for changes to the following,  either before or after 1 April 2026:

• submitting the renew registration application – this function will be removed from DORS on 1 April 2026, please see Review registration
• updating contact details including email address, telephone numbers, customer service contact telephone number and/or email address
• adding products (medical device name/trade name, model/ version, catalogue/reference detail, UDI-DI, for example) to registered devices
• removing devices or products from your registration record (that you no longer manufacture, or migrated devices with Pseudo Global Medical Device Nomenclature (GMDN®), where applicable)
• updating registered device and product fields that were not populated at time of registration
• updating obsolete Global Medical Device Nomenclature (GMDN®)
• uploading and linking new conformity assessment and self-certification declaration documents to registered devices, providing the documents are consistent with the legislation that the device was originally registered under (if you wish to change the legislation, for example, from MDD/AIMD/IVDD to UK MDR 2002 part II,III or VI, or to MDR/IVDR, a new registration is required and the statutory fee will be payable unless the GMDN® Category of the new registration remains the same as the existing registration under different legislation)
• unregistering your account or the accounts of represented manufacturers that you no longer represent
• adding or deactivating importers

Registration of certain medical devices that have expired/expiring CE certificates

In March 2023, the EU revised the EU MDR transitional arrangements to extend the validity of EU MDD and EU AIMDD CE certificates in limited circumstances for certain medical devices. Such certificates can be relied on for placing a medical device on the Northern Ireland and Great Britain markets until the dates set out in the guidance linked below.

For more information about this, and the steps you would need to take to rely on an expired EU MDR or EU AIMD CE certificate that has been deemed valid under the EU MDR, see:

• guidance on regulation of medical devices in the UK
• update on EU MDR revised transitional arrangements
• guidance on registration of medical devices with an expired/expiring CE certificate that is valid under EU Medical Devices Regulations (EU MDR).

As set out in that guidance, you will need to upload a letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. Alternatively, if you do not hold a notified body letter you will need to complete and upload the following template letter: EU MDR Article 120 Extension Confirmation Template.

Registration of certain medical devices which are EU MDD Class I reusable surgical instruments or EU MDD Class I medical devices upclassified from Class I

We have prepared guidance on registration of certain medical devices which are EU MDD Class I medical devices which are a) reusable surgical instruments or b) upclassified under EU MDR.

This contains information to be aware of if you are registering the following types of medical devices with MHRA as self-declared as meeting requirements in EU MDD:

• guidance on registration of EU MDD Class I reusable surgical instruments that would require notified body involvement in their assessment under EU MDR
• guidance on registration of EU MDD Class I medical devices that are upclassified under EU MDR

Registration of certain IVD devices that have expired/expiring CE certificates 

In June 2024, the EU revised the EU IVDR transitional arrangements to extend the validity of EU IVDD CE certificates in limited circumstances for certain IVD devices. Such certificates can be relied on for placing an IVD device on the Northern Ireland and Great Britain markets until the dates set out in the guidance linked below. 

For more information about this, and the steps you would need to take to rely on an expired EU IVDD CE certificate that has been deemed valid under the EU IVDR please see the following: 

• guidance on regulation of medical devices in the UK 
• guidance on registration of IVD devices with an expired/expiring CE certificate that is valid under EU IVDR 

As set out in that guidance, you will need to upload a letter issued by the notified body stating the receipt of the manufacturer’s application for conformity assessment and the conclusion of a written agreement. Alternatively, if you do not hold a notified body letter you will need to complete and upload EU IVDR Article 110 Extension Confirmation Template.

Registering IVD devices which the EU IVDR up-classifies from general IVD device  

We have prepared IVD device registration guidance for information to be aware of if you are registering IVD devices that are upclassified to either a Class B, C, or D IVD device and would require notified body involvement in their assessment under EU IVDR: 

• guidance on registration of EU IVDD general IVD devices that are upclassified under the EU IVDR

Public register of manufacturers

Once registered, your company name, address and registered medical device types are added to the Public Access Registration Database (PARD) for medical device registration.

Records are listed by:

• manufacturer name
• address
• MHRA Reference (account) number
• devices registered with MHRA by medical device type (Global Medical Device Nomenclature (GMDN®) Term)
• Brand/trade names of registered devices (available from 23 February 2026)
• 5-digit GMDN® codecode*

UK Responsible Person or Northern Ireland Authorised Representative name and address is displayed within the manufacturer record (if applicable).

In vitro diagnostic medical devices registered as undergoing performance evaluation study are not published on this database.

The MHRA uses terminology to describe devices and classification per the International Medical Device Regulators Forum (IMDRF), see: Common Data Elements for Medical Device Identification.

Brand/trade/proprietary names of registered devices are not currently displayed on PARD.

If your registration is not displaying on PARD or your devices are displaying as ‘Devices pending update by manufacturer’, access your account and take any necessary action to bring your registration up to date. See See Review registration and  and Making changes to your registration.

*^{Global Medical Device Nomenclature (GMDN®) is the globally recognised system for naming and classifying all medical devices (including implantables, medical equipment, consumables, and diagnostic devices), providing regulators, healthcare professionals, and manufacturers with a common language to communicate and share information by facilitating accurate identification, tracking, and reporting of medical devices. The GMDN Agency is a registered UK charity and non-profit organisation responsible for the ongoing maintenance of the GMDN database. The latest GMDN Agency annual report is available from the [Charities Commission website. For more information, please visit: https://www.gmdnagency.org/.}

^{GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2026. Used under licence from The GMDN Agency Ltd.}

^{The information provided on this site includes data supplied by The GMDN Agency (‘GMDN Content’), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency.}

^{None of the GMDN® content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.}

Reference guides

These guides provide instructions on how to use the device registration and Certificates of Free Sale System.

The screenshots in the reference guides may not exactly match the latest screens in the system. Changes will be updated in the guides as soon as possible. Always follow the system on-screen messages and information.

• Account Management Reference Guide March 2025 (PDF, 2.17 MB, 42 pages)
• Device Registration Reference Guide March 2025 (PDF, 6.04 MB, 101 pages)

Video tutorials

These video tutorials show you an overview of how to use our Device Registration and Certificates of Free Sale System.

The video tutorial screens may not exactly match the latest screens in the system. Changes will be updated in the videos as soon as possible. Always follow the system on-screen messages and information.

Any fees referred to in the video tutorials are for demonstration purposes only. Refer to the Fees section for current fees.

The guides below are to be viewed in conjunction with the above reference guides:

• Review page
• Registering a general medical device
• Registering an in vitro diagnostic medical device
• Registering an IVD for Performance Evaluation
• Registering a custom-made medical device
• Registering a system or procedure pack
• Using the bulk product upload template
• Save & exit – save draft application
• Making payments by BACS/CHAPS
• Making payments by worldpay
• Updating role to UK Responsible Person
• Edit organisation details
• Adding represented organisations
• Add importer
• Deactivate importer
• Manage registered devices - Add or remove products
• Manage registered devices - Manage conformity documents
• Manage registered devices - Delete devices
• Update registered devices and update products individually
• Update multiple products
• Resolving product data errors
• Update Obsolete GMDN®
• Adding other addresses (Billing, manufacturing site)
• Upload new Letter of Designation
• Review and renew registration
• Unregister manufacturer

Contact

If you have any queries or complaints about the registration process, email device.registrations@mhra.gov.uk, quoting your reference number.

If you are already registered with us and have a question about your registration details, email device.registrations@mhra.gov.uk quoting your reference number.

If you have read the guidance on how to tell if your product is a medical device and:

• are not sure whether your products qualify as medical devices, or
• are not sure which risk class applies to your medical devices

email devices.borderlines@mhra.gov.uk with the full details of your specific product for further advice.