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

In Great Britain devices must conform to the听听(SI 2002 No 618, as amended) (鲍碍听惭顿搁听2002) as they apply in Great Britain so that 听they can be placed on the market and registered with the听MHRA.

Registration requirements differ for听Northern Ireland.

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

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

Therefore, you are not permitted to make any claims to this effect, including the use of any听MHR础听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听MHRA, we may request further technical documentation from you to demonstrate that your products conform to the requirements of the听

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听听that you inform the听MHR础听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听you have manufactured
• IVDs听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听MHR础听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听MHRA.

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

Where any changes to registrations are made, a statutory fee may apply per application. Please see our听Fees听蝉别肠迟颈辞苍.

Registration for the Northern Ireland market

In some circumstances, there is a requirement to register with the听MHR础听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听鈥� Non-custom-made devices听听

Certain medical devices that are placed on the Northern Ireland market need to be registered with the鈥疢HRA 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听in order to听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鈥疢HRA.听听

Where听a听Great Britain manufacturer听has appointed听an EU-based authorised representative, the Great Britain-based manufacturer must register all device classes other than Class I devices and general鈥疘VDs鈥�(that are not for self-testing)鈥痺ith the鈥疢HRA.听听

In certain cases, manufacturers based outside the EU or听EE础听must be registered with the MHRA. This requirement does not apply to manufacturers placing Class I medical devices or general鈥疘VDs鈥�(that are not for self-testing)鈥痮n the Northern Ireland market in cases where:听

• the manufacturer is based in the EU or鈥疎EA, or听
• the manufacturer is based outside Great Britain, Northern Ireland, the EU,听or EE础听and has appointed an EU-based authorised representative.

From 28 May 2026听

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

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

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

Registration requirements听for听Northern Ireland听鈥� Custom-made devices听

听require all manufacturers, regardless of geographical location, to register their custom-made devices with the听MHR础听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听custom-made devices with the听MHRA on behalf of the manufacturer.听听听听

Where an EU-based authorised representative has been appointed, the manufacturer must register all its custom-made devices听with the听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听MHR础听by emailing听Device.Registrations@mhra.gov.uk听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鈥檚 details to the MHRA, including the importer鈥檚 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听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 .

鈥渕edical device鈥� means听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听which鈥�

(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.

鈥渋n vitro听diagnostic medical device鈥� means a medical device which鈥�

(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听for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information鈥�

(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听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听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听Borderline products: how to tell if your product is a medical device
• 听(GMDN)庐 Code and Term to describe your device
• basic听UDI-DI听(if applicable)
• medical device name (brand/trade/proprietary name)
• model or version detail
• catalogue/reference number
• UDI-DI听(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听GMDN庐听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听GMDN庐听Agency to find and select the appropriate听GMDN庐听Terms in our online registration system (DORS).

However, please note that听GMDN庐听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听Borderline products: how to tell if your product is a medical device.

For a full view of the fields required, refer to the听 (MS Excel Spreadsheet, 40.9 KB).

Custom-made devices

There is further information about听custom-made devices.听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听MDD听or EU听AIMDD听can no longer be placed on the Great Britain or听Northern Ireland听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听MDD听or EU听AIMDD听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听MDD听or EU听AIMDD听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听Northern Ireland听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听GMDN庐
• 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听GMDN庐.

IVDs听undergoing performance evaluation

IVDs听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.听听

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

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 鈥� to 鲍碍听惭顿搁听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听MHRA

Under regulation 34A of the Medical Devices Regulations 2002 no antigen or molecular detection听coronavirus test may be placed on the UK听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听MHRA as set out in this guidance.

Registration applications for coronavirus听test devices will not be accepted by the听MHR础听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听MHRA, you may be contacted to specify the exemption applicable under the Medical Devices Regulations 2002 (as amended by听听before your听MHR础听registration application is accepted.

For full details see听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听听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听MHR础听(the UK Competent Authority) does not represent any form of accreditation, certification, approval or endorsement by the听MHRA.

Therefore, you are not permitted to make any claims to this effect, including the use of any听MHR础听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

础听听 applies for each registration in a new GMDN庐 Level 2 Category (or Level 1 Category where no Level 2 exists).

厂别别听Current MHRA fees听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听.

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鈥檚 finance team.

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

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

厂别别听making changes to your registration听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听GMDN庐 Categories (or Level 1 Category where no Level 2 exists) their devices are registered under. If multiple听GMDN庐 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听GMDN庐 Category (or Level 1 Category where no Level 2 exists). Some products fall under more than one Level 2听GMDN庐 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鈥檚 annual fee is based on the Level 2听GMDN庐 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 拢300 per year, per Level 2听GMDN庐 Category (or Level 1 Category where no Level 2 exists). This fee will change annually.

Please see the听听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听Making changes to your registration听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听the MHR础听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 concerning registration of persons placing medical devices on the Great Britain or market, and , 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听MHRA, we encourage you to make the necessary changes to your registered information as and when they occur.

听(Device Online Registration System). This is for existing customers only.

If you registered with the听MHR础听before 1 July 2018 and have a registration number that begins with 鈥楥A, or听IVD鈥� or your registration does not appear on the听Public Access Registration Database (PARD)听you will need to re-register your organisation details and devices on the听DORS听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.

础听statutory fee听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听GMDN庐 Category that already exists on the account
• changing device characteristics, for example, incorrect听GMDN庐 assignment, class, from non-sterile to sterile or vice versa., trade/brand name, UDIs or any field that cannot be updated in DORS 鈥� the device will need to be re-registered. The fee will be payable for new Level 2听GMDN庐 Categories
• changing status of an听IVD, for example a change from 鈥榩erformance evaluation鈥� to 鈥榥ew鈥� - you will need to register the听IVD听device again. No fee will be payable if the听GMDN庐 Category of the new registration remains the same as the 鈥榩erformance evaluation鈥� registration
• changing the legislation of a device (for example, from听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听GMDN庐 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,听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庐), where applicable)
• updating registered device and product fields that were not populated at time of registration
• updating obsolete Global Medical Device Nomenclature (GMDN庐)
• 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听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听GMDN庐 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听MDD听and EU听AIMDD听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听regulation of medical devices in the UK
• update on听EU MDR revised transitional arrangements
• guidance on听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鈥檚 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:听.

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

We have prepared听guidance on registration of certain medical devices which are EU听MDD听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听MDD:

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

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

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

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:听

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

As set out in that guidance, you will need to upload a letter issued by the notified body stating the receipt of the manufacturer鈥檚 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听.

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

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

• guidance on鈥�registration of EU IVDD general听IVD听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听.

Records are listed by:

• manufacturer name
• address
• MHR础听Reference (account) number
• devices registered with听MHR础听by medical device type (Global Medical Device Nomenclature (GMDN庐) Term)
• Brand/trade names of registered devices
• 5-digit听GMDN庐 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 MHR础听uses terminology to describe devices and classification per the International Medical Device Regulators Forum (IMDRF), see:听.

If your registration is not displaying on PARD, access your account and take any necessary action to bring your registration up to date. 厂别别听Review registration听and听Making changes to your registration.

*Global Medical Device Nomenclature (GMDN庐) 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听GMDN听Agency is a registered UK charity and non-profit organisation responsible for the ongoing maintenance of the听GMDN听database. The latest听GMDN听Agency annual report is available from the [Charities Commission website. For more information, please visit:听.

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

The information provided on this site includes data supplied by The听GMDN听Agency (鈥楪MDN听Content鈥�), which is used under licence from The听GMDN听Agency. Any data/information suppliers who wish to extract听GMDN听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听GMDN听Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact听.

None of the听GMDN庐 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听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.

• (PDF, 2.81 MB, 47 pages)
• (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听Fees section听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听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听device.registrations@mhra.gov.uk听quoting your reference number.

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

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

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