All medical devices, including in vitro diagnostic 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.

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.

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 to demonstrate that your products conform to the requirements of the Medical Device Regulations.

Registration for the Great Britain Market

The following requirements apply to place your device on the Great Britain 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

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. If the role is not updated by 30 March 2026 the account will be closed and a new account must be created.

The UK Responsible Person will then assume the responsibilities of the manufacturer in terms of registering the device with the MHRA.

See guidance for more information about the role of the UK Responsible Person.

Where any changes to registrations are made, a statutory fee may apply per application. Please see our Fees section.

Registration for the Northern Ireland market

In some circumstances, there is a requirement to register with the MHRA when you first place your device on the Northern Ireland market.

Manufacturers based outside Northern Ireland or the EU are required to appoint an EU or Northern Ireland based Authorised Representative if they wish to place devices on the Northern Ireland market.

Registration requirements for Northern Ireland – Non-custom-made devices

Certain medical devices that are placed on the Northern Ireland market need to be registered with the MHRA under the UK MDR 2002. The precise requirements depend on the location of the manufacturer, the location of the authorised representative and the device class, as set out below.

Until 27 May 2026

Great Britain manufacturers must appoint an authorised representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market. Where a Northern Ireland-based authorised representative is appointed, the authorised representative needs to register devices of all classes with the MHRA.

Where a Great Britain manufacturer has appointed an EU-based authorised representative, the Great Britain-based manufacturer must register all device classes other than Class I devices and general IVDs (that are not for self-testing) with the MHRA.

In certain cases, manufacturers based outside the EU or EEA must be registered with the MHRA. This requirement does not apply to manufacturers placing Class I medical devices or general IVDs (that are not for self-testing) on the Northern Ireland market in cases where:

the manufacturer is based in the EU or EEA, or
the manufacturer is based outside Great Britain, Northern Ireland, the EU, or EEA and has appointed an EU-based authorised representative.

From 28 May 2026

From 28 May 2026, all medical devices (other than custom-made devices) must be registered on the European Database on Medical Devices (EUDAMED) prior to placement on the EU and Northern Ireland markets. From this point, MHRA registration will not be required.

Great Britain-based manufacturers will continue to require an authorised representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market.

Custom-made devices do not need to be registered on EUDAMED. Such devices must continue to be registered with the MHRA as set out below.

Registration requirements for Northern Ireland – Custom-made devices

The Northern Ireland Regulations 2021 require all manufacturers, regardless of geographical location, to register their custom-made devices with the MHRA within 28 days of being made available on the Northern Ireland market.

Where a Northern Ireland-based authorised representative has been appointed, the authorised representative may register custom-made devices with the MHRA on behalf of the manufacturer.

Where an EU-based authorised representative has been appointed, the manufacturer must register all its custom-made devices with the MHRA.

UK manufacturers who do not already have a Device Online Registration System (DORS) account must create one and register their custom-made devices. You only need one DORS account to register for both the Great Britain and Northern Ireland markets.

Contact the MHRA by emailing Device.Registrations@mhra.gov.uk for instructions 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

Registration of importers

A Great Britain-based importer must inform the relevant manufacturer or UK Responsible Person of their intention to import a device for placement on the Great Britain market.

In these circumstances, the manufacturer or UK Responsible Person is responsible for submitting the importer’s details to the MHRA, including the importer’s place of business in Great Britain.

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.

Northern Ireland-based importers must comply with importer obligations in the EU Medical Devices Regulation (EU MDR) (2017/745) or EU in vitro Diagnostic Medical Devices Regulation (EU IVDR) (2017/746). From 28 May 2026, EUDAMED registration of Northern Ireland importers will be required.

Information required when registering your devices with the MHRA

Before attempting to register devices with the MHRA, please ensure that your device meets the definition of a medical device or an in vitro diagnostic medical device in accordance with the interpretation set out in Regulation 2 of the UK MDR 2002, as amended.

“medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application which—

(a) is intended by the manufacturer to be used for human beings for the purpose of-

(i) diagnosis, prevention, monitoring, treatment or alleviation of disease,

(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

(iii) investigation, replacement or modification of the anatomy or of a physiological process, or

(iv) control of conception; and

(b) does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means, and includes devices intended to administer a medicinal product or which incorporate as an integral part a substance which, if used separately, would be a medicinal product and which is liable to act upon the body with action ancillary to that of the device.

“in vitro diagnostic medical device” means a medical device which—

(a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and

(b) is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information—

(i) concerning a physiological or pathological state,

(ii) concerning a congenital abnormality,

(iii) to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or

(iv) to monitor therapeutic measures, and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination

If you are unsure if your device meets the above definitions, and particularly if you are registering with a self-certification conformity declaration, please see Borderline products: how to tell if your product is a medical device

When registering devices with the MHRA, you must provide the information listed below. These lists are non-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 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 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 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) 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 Borderline products: how to tell if your product is a medical device.

For a full view of the fields required, refer to the Manufacturer and Device and Product and Importer Attributes (MS Excel Spreadsheet, 40.9 KB).

Custom-made devices

There is further information about custom-made devices. 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 MDD or EU AIMDD can no longer be placed on the Great Britain or Northern 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 MDD or EU AIMDD requirements) for the Great Britain market only, with a suitable accompanying custom-made statement.

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

Custom-made devices that comply with the EU MDD or EU AIMDD and were placed on the market in an EU member state, prior to 26 May 2021, can still be registered with MHRA for the purposes of placing on the Northern Ireland 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 performance evaluation studies in the UK must be registered by the manufacturer, UKRP or Northern Ireland Authorised representative by the time the study commences.

IVDs that are subject to existing ongoing performance evaluations (commenced before 31 December 2020) must also be 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 coronavirus test may be placed on the UK market without first being validated against minimum performance standards through a coronavirus test device approvals desktop review. Manufacturers or distributors supplying coronavirus test devices must apply to MHRA as set out in this guidance.

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

For full details see COVID-19 test approval: how to apply.

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.

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

The MHRA is extending the deadline for payment of the Annual Fee by one month, to 31 July 2026, to give customers additional time to adjust to the new fee structure and ensure that the correct devices are registered. Accounts that have not paid the Annual Fee will remain active during this extended period.

The MHRA is also aware that a small number of customers have registered devices that are technically classified as being put into service only. We will soon publish updated guidance to provide greater clarity on which devices should be registered with us and to outline any further actions that may be required.

A statutory fee applies for each registration in a new GMDN® Level 2 Category (or Level 1 Category where no Level 2 exists).

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.

A new fee structure came into effect on 1 April 2026. It has replaced the previous one-off registration fee regime.

Manufacturers are charged annually based on how many Level 2 GMDN® Categories (or Level 1 Category where no Level 2 exists) their devices are registered under. If multiple GMDN® and products are registered under one Level 2 Category (or Level 1 Category where no Level 2 exists), they will only be charged once per year for that Level 2 GMDN® Category (or Level 1 Category where no Level 2 exists). Some products fall under more than one Level 2 GMDN® Category (or Level 1 Category where no Level 2 exists), 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 is payable for the registration on a pro rata basis.

Calculation of each manufacturer’s annual fee is based on the Level 2 GMDN® Categories that their registrations fall under on 31 March of each year.

The unit cost for the fee from 1 April 2026 to 31 March 2027 is £300 per year, per Level 2 GMDN® Category (or Level 1 Category where no Level 2 exists). This fee will change annually.

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

It is important that customers review their registration account regularly to ensure all data is correct and to enable correct fee calculation.

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

Guidance on how the device registration fee is calculated and paid

Read our guidance about how the fee structure from 1 April 2026 works: DORS Fees Guidance - New fee structure from 1 April 2026 (PDF, 447 KB, 24 pages)

We welcome your feedback on this guidance. Please complete our short survey to help us make clarifications to the guidance and answer your questions.

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 and 19 (general medical devices, regulations 21A and 21 B (active implantable medical devices), and regulations 33A and 44 (in vitro diagnostic medical 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 market, and Regulation 7 of the Medical Devices (Northern Ireland) Regulations 2021, as and when they occur.

The previous Renew registration function was removed from DORS on 1 April 2026. You are still 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.

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 may be payable 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 vice versa., 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/AIMDD/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:

address
company name
uploading new letter of designation for represented manufacturers
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/AIMDD/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
5-digit GMDN® code*

UK Responsible Person or Northern Ireland Authorised Representative name and address are displayed within the manufacturer record (if applicable). It is not currently possible to search PARD by Representative.

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.

If your registration is not displaying on PARD, access your account and take any necessary action to bring your registration up to date. See Review registration 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 April 2026 (PDF, 2.81 MB, 47 pages)
Device Registration Reference Guide April 2026 (PDF, 6.61 MB, 102 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:

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.

Register medical devices to place on the market