Register medical devices to place on the market

All medical devices, including 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).

Registering your devices with the MHRA does not mean that we give you any form of:

• accreditation
• certification
• approval for the device

You should not claim this in any marketing materials, on the packaging or in the instructions for use.

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.

Who must register

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

Placing a 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

Register your device to place on the Great Britain market

If the manufacturer is based outside of 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, will be suspended from 1 January 2022 until the UK Responsible Person has updated their role.

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 £100 statutory fee will apply per application.

Distributors and suppliers are not required to register with the MHRA.

In cases where the Great Britain importer is not the UK Responsible Person, the importer must inform the relevant manufacturer or UK Responsible Person of their intention to import a device.

In such cases, the UK Responsible Person or the manufacturer must provide the MHRA with the importer details, including their place of business in Great Britain.

Placing a device on the Northern Ireland market

In some circumstances, it is a requirement of the UK MDR 2002 that you inform the MHRA when you first place your device on the Northern Ireland market. The precise requirements depend on the location of the manufacturer, the location of the Authorised Representative and the device class. Please see below for further information.

Register your device to place on the Northern Ireland market

Requirements for non-UK manufacturers

If you are a non-UK manufacturer, you may be required to appoint a single UK Responsible Person within the UK for IVD List A products, IVD List B products and self-test IVDs that are placed on the Northern Ireland market. A UK Responsible Person is not required on order to place IVDs that do not fall within these device classifications on the Northern Ireland market.

Non-UK manufacturers are not required to appoint a UK Responsible Person for the purpose of placing general medical devices and active implantable medical devices on the Northern Ireland market.

The requirement to appoint a UK Responsible Person for the purposes of placing an IVD on the Northern Ireland market applies in cases where:

• you are a manufacturer based in the EU or the EEA; and

• place IVDs on the Northern Ireland market that have not already been registered with an EU Competent Authority.

• you are a manufacturer based outside the UK, the EU and the EEA; and
• have an Authorised Representative based outside Northern Ireland; and
• place IVDs on the Northern Ireland market that have not already been registered with an EU Competent Authority.

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.

Requirements for Great Britain-based manufacturers placing devices on the Northern Ireland market

Great Britain manufacturers must designate an Authorised Representative based in the EU or Northern Ireland in order to place a device on the Northern Ireland market.

Where an EU-based Authorised Representative is appointed, the Great Britain-based manufacturer must register all device classes other than Class I devices and general IVDs with the MHRA.

Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative must register all devices with the MHRA.

Please note that new requirements have recently been introduced regarding the registration of custom-made devices in Northern Ireland. Please see below for further information.

Distributors and suppliers are not required to register with the MHRA.

Registration of importers

The Northern Ireland-based Authorised Representative or UK Responsible Person must provide the MHRA with details of the person placing the product on the Northern Ireland market if the person placing the product on the market is not:

• The manufacturer, or
• The Northern Ireland-based Authorised Representative, or
• The UK Responsible Person (for IVDs only)

Registration of custom-made devices in Northern Ireland

We have recently introduced legislation to supplement provisions that were introduced in Northern Ireland on 26 May 2021 when the EU Medical Devices Regulation (2017/745) (EU MDR) took effect. This legislation has introduced a requirement to register all custom-made devices with the MHRA within 28 days of being made available on the Northern Ireland market.

When you must register

When to register a device on the Great Britain market

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

From 1 January 2022, non-UK manufacturers will require a UK Responsible Person for the purposes of registering devices placed on the Great Britain market. A Northern Ireland-based Authorised Representative will no longer be able to register devices on a manufacturer’s behalf for the Great Britain market.

Failure to register your devices will mean that you are unable to lawfully place your device on the Great Britain market.

When to register a device on the Northern Ireland market

There is currently a requirement to register with the MHRA, certain medical devices (including IVDs, custom-made devices and systems and procedure packs) that are placed on the Northern Ireland market.

This requirement does not apply to manufacturers placing Class I medical devices or general IVDs on the Northern Ireland market in cases where:

• the manufacturer is based in the EU or EEA, OR
• the manufacturer is based outside Northern Ireland, the EU or EEA and has appointed an EU-based Authorised Representative.

For information on registration of custom-made devices in Northern Ireland please see above.

Information required when registering your devices with the MHRA

You are asked to provide the following information when registering your devices with us. Please note 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 e.g. 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). This 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.

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, please 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.

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. YouIf doyou notwould needlike tofurther beguidance aon memberwhether ofcertain products are medical devices in the GMDNUK, Agencyplease tosee findBorderline andproducts: selecthow theto appropriatetell GMDNif Termsyour inproduct ouris onlinea registrationmedical system.device.

For a full view of the fields required, gorefer to the Manufacturer and Device and Product and Importer Attributes (MS Excel Spreadsheet, 54.4KB) list.

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, we consider it good practice for you to provide us with a copy of the instructions for use and the device labelling.

Please 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.

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 are required to:

• 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 time the study commences
• IVDs that are subject to existing ongoing performance evaluations (commenced before 31 December 2020) must also be registered
• Non-UK manufacturers conducting performance evaluation studies in the UK will require a UK Responsible Person or a Northern Ireland-based Authorised Representative 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 UK market without first being validated against minimum performance standards through a Coronavirus Test Device Approvals desktop review. Persons wishing to supply, put into service or place on the UK market a coronavirus test device, need to apply to the UK’s Health Security Agency (UKHSA) for approval.

Registration applications for covid test devices will not be accepted by the MHRA until the devices have received Coronavirus Test Device Approval (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 will 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 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.

Registering your devices with the MHRA does not mean that we give you any form of:

• accreditation
• certification
• approval for the device

You should not claim this in any marketing materials, on the packaging or in the instructions for use.

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

A statutory fee of £100 applies for each registration application.

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

If you need to update any information within an existing registration, you may be charged a £100 statutory fee. This includes updating a registration from a UK Authorised Representative to a UK Responsible Person.

See below for information on making changes to your registration.

Review registration

You should review your registration frequently to make sure it is up to date. It is a legal requirement to inform MHRA of any changes to your registration per section 7A (general medical devices), section 33A (in vitro diagnostic medical devices) and section 21A (active implantable medical devices) of the Medical Devices Regulations (2002) SI 618 (as amended) concerning registration of persons placing medical devices on the market, as and when they occur. Please do not wait for reminder emails.

Please review all your devices and products to ensure the data is correct and update any data fields that were not previously populated using the Update registered devices and products functionality. There is no fee to use this function. In particular we urge you to provide the UDI-DIs for your devices as these will be crucial for monitoring and ensuring patient safety.

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 creation 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 no fee for this application.

If you do not review your registration and submit the Renew registration application 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. Please follow the Renew Registration instructions in the Account Management Reference Guide and watch the Renew Registration video tutorial.

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 registration fee of £100 per application.

Making changes to your registration

If you are already registered with the MHRA, we encourage you to confirm the accuracy of your registered information in line with any emails that you receive from MHRA DORS.

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 Database for Medical Device Registration (PARD) you will need to re-register your details and devices on the DORS system.

Please note that we now ask for more detailed information on your devices.

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

A £100 statutory fee is chargeable for changes to the following:

• address
• company name
• adding devices to your registration record
• status of an IVD, for example a change from ‘performance evaluation’ to ‘new’
• change of role from Authorised Representative or UK Responsible Person (fee chargeable per represented organisation)
• change of UK Responsible Person

You will not currently be charged the statutory fee for these changes:

• contact details including email address, telephone numbers
• adding products (medical device name, model or version, catalogue/reference detail, UDI-DI, for example) to registered devices
• updating conformity assessment and self-certification declaration documents
• updating specific data fields that were previously left empty when registering
• removing devices or products from your registration record

Public register of manufacturers

Once registered, your company name and address are added to the Public Access Database for Medical Device Registration.

Records are listed by:

• manufacturer name
• address
• UK Responsible Person or Northern Ireland Authorised Representative name and address (if applicable)
• MHRA reference (account) number
• all the devices registered with us by GMDN term

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

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 (PDF, 2.02 MB, 41 pages)
• Device Registration Reference Guide (PDF, 5.59 MB, 85 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.

These 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
• Update registered devices and products
• Update Obsolete GMDN
• Adding other addresses (Billing, manufacturing site)
• Upload new Letter of Designation
• Renew registration
• Unregister manufacturer

Contact

If you are not sure whether you should register your devices with the MHRA, email info@mhra.gov.uk.

If you have any queries or complaints about the registration process, please 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 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.