Register medical devices to place on the market

All medical devices, including in vitro diagnostic devices (IVDs),(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 the Medical Devices Regulations 2002 (SI (SI 2002 No 618, as amended) (UK MDR 2002) as they apply in Great Britain so that  theythey can be placed on the market and registered with the MHRA.

Registration requirements differ for 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 Competentcompetent Authority)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 to demonstrate that demonstrates your products conform to the requirements of the 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 the UK MDR 2002 that 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 IVDs you have manufactured
• IVDs undergoing 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 our Fees section. section for changes from 01 April 2026.

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

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 (thatgeneral IVDs (that are not for self-testing) with the MHRA.  

In certain cases, manufacturers based outside the EU or EEA mustor EEA must be registered with the MHRA. This requirement does not apply to manufacturers placing Class I medical devices or general IVDs (thatgeneral 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 EEA, or 
• the manufacturer is based outside Great Britain, Northern Ireland, the EU, or EEA and 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 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 emailing Device.Registrations@mhra.gov.uk for 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)® (GMDN)® Code and Term to describe your device
• basic UDI-DI (ifbasic UDI-DI (if applicable)
• medical device name (brand/trade/proprietary name)
• model or version detail
• catalogue/reference number
• UDI-DI (if 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® Codewhich 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® Agencythe GMDN® Agency to find and select the appropriate GMDN® Termsappropriate GMDN® Terms in our online registration system (DORS).

However, please note that GMDN® isthat 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 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, provide us with a copy of the instructions for use and the device labelling.

Custom-made devices under the EU MDD orEU MDD or EU AIMDD canEU 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 orEU MDD or EU AIMDD requirements)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 orEU MDD or EU AIMDD andEU 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®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®.that GMDN.

IVDs undergoing IVDs undergoing performance evaluation

IVDs subjectIVDs 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 thatIVDs 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 coronavirusdetection 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. Manufacturers or distributors supplying coronavirusCOVID-19 testtests devices must apply to MHRA as set out in this guidance.

Registration applications for coronavirus testcovid 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 coronavirusCovid 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.accepted .

For full details see COVID-19For testindustry approval:and howmanufacturers: toCOVID-19 applytests and testing kits.

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

You need to create an account on the the MHRA DORS before 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 A statutory fee  applies for each registration in a new GMDN® Level 2 Category (or Level 1 Category where no Level 2 exists).application.

See See Current MHRA fees for 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 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®)(GMDN®) with a cumulative maximum of 20,000 products (medical device brand/trade/proprietary name, model/version, catalogue/reference, UDI-DI etc.)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 structureis cameplanned to come into effect on 1 April 2026.2026 and will apply for the financial year 2026-27. It haswill replacedreplace the previouscurrent one-off registration fee regime.

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

Calculation of each manufacturer’s annual2026/27 fee iswill be based on the Level 2 GMDN®2 GMDN® Categories that their registrations fall under on 31 March of each year.2026.

The estimated unit cost for the fee from 1 April 2026 towill 31be Marchin 2027the isregion of £300 per year, per Level 2 GMDN® Category (or Level 1 Category where no Level 2 exists).GMDN® This fee will change annually.Category.

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

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

In particular please check and toupdate enablethe correctfollowing, feeas calculation.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 see Making changes to your registration for 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 (general(custom-made general medical devices,devices), regulations 21A (active implantable medical devices) and 2121B B(custom-made (activeactive implantable medical devices), and regulations 33A (in vitro diagnostic medical devices) and 44 (in vitro diagnostic medicalself-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 market,Northern Ireland markets, as and Regulationwhen 7they 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 DevicesDevice (NorthernNomenclature Ireland)(GMDN®), Regulationswhere 2021applicable).

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 whenensuring theypatient occur.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 previousfee 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 waswill be removed from DORS on 1 April 2026. You arewill 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 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 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®2 GMDN® Category that already exists on the account
• changing device characteristics, for example, incorrect GMDN®incorrect GMDN® assignment, class, from non-sterile to sterile or vicev.v., 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®2 GMDN® Categories
• changing status of an IVD,an IVD, for example a change from ‘performance evaluation’ to ‘new’ - you will need to register the IVD devicethe IVD device again. No fee will be payable if the GMDN®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/IVDDfrom 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®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: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,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®),(GMDN®), where applicable)
• updating registered device and product fields that were not populated at time of registration
• updating obsolete Global Medical Device Nomenclature (GMDN®)(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/IVDDfrom 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®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 andEU EU AIMDD CEMDD 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 on regulation of medical devices in the UK
• update on on EU MDR revised transitional arrangements
• guidance on 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: letter: EU MDR Article 120 Extension Confirmation Template.

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

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

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

Registration of certain IVD devicescertain 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.certain IVD devices. Such certificates can be relied on for placing an IVD devicean 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 devicesof 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 upload EU IVDR Article 110 Extension Confirmation Template.

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

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

• guidance on registration of EU IVDD general IVD devicesgeneral 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 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®)(GMDN®) Term)
• Brand/trade names of registered devices (available from 23 February 2026)
• 5-digit GMDN®5-digit GMDN® code*

UK Responsible Person or Northern Ireland Authorised Representative name and address areis 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: see: Common Data Elements for Medical Device Identification.

If your registration is not displaying on PARD,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 Review registration and Making changes to your registration.

*Global*^{Global Medical Device Nomenclature (GMDN®)(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 AgencyThe GMDN Agency is a registered UK charity and non-profit organisation responsible for the ongoing maintenance of the GMDN database.the GMDN database. The latest GMDN Agencylatest GMDN Agency annual report is available from the [Charities Commission website. For more information, please visit: visit: https://www.gmdnagency.org/.}

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

^{The information provided on this site includes data supplied by The GMDN AgencyThe (‘GMDN Content’),GMDN Agency (‘GMDN Content’), which is used under licence from The GMDN Agency.The GMDN Agency. Any data/information suppliers who wish to extract GMDN Contentextract 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.The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact contact The GMDN AgencyThe GMDN Agency.}

^{None of the GMDN®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 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 AprilMarch 20262025 (PDF, 2.812.17 MB, 4742 pages)
• Device Registration Reference Guide AprilMarch 20262025 (PDF, 6.616.04 MB, 102101 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 the Fees section for for current fees.

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

• Paying Annual Fee
• Paying for new device registrations
• Review page
• Registering a general medical device
• Registering an in vitro diagnostic medical device
• Registering an IVD foran 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®Obsolete GMDN®
• Adding other addresses (Billing, manufacturing site, and Authorised Representative)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 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 email device.registrations@mhra.gov.uk quoting quoting your reference number.

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

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

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