Overview

From 1 January 2021 the following devices in Great Britain (England, Wales and Scotland) will need to be registered with the MHRA under existing arrangements:

• Class I medical devices
• IVDs
• custom-made devices

All other classes of device placed on the Great Britain market will require registration with the MHRA subject to grace periods over the following 12 months, depending on the class of devices.

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 registered with the MHRA. Great Britain is England, Wales and Scotland.

The MHRA will only accept registration of devices from manufacturers or UK Responsible Persons that have a place of business 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.

We may request further technical documentation from you that demonstrate 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 (England, Wales and Scotland).

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 will need to appoint a UK Responsible Person who has a registered place of business in the UK.

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

You will be required to appoint a UK Responsible Person and update your registration information with the details 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 will be required to inform the relevant UK Responsible Person of their intention to import a device.

In such cases, the UK Responsible Person will be required to provide the MHRA with a list of device importers.

If you have already registered your device with the MHRA for the purposes of Great Britain, it will not need to undergo any further registration in Northern Ireland, so long as you have indicated that the device is also for the Northern Ireland market. Such devices must meet the regulatory requirements for the Northern Ireland market.

Placing a device on the Northern Ireland market

In some circumstances, it will be a requirement of the UK MDR 2002 from 1 January 2021 that you inform the MHRA when you first place your device on the Northern Ireland market.

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

• Class I devices, custom-made devices or general IVDs you have manufactured, but only where the manufacturer or its Authorised Representative are based in Northern Ireland
• Class 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
• IVD List A products, IVD List B products and self-test IVDs you have manufactured
• IVDs undergoing performance evaluation

Register your device to place on the Northern Ireland market

The manufacturer will need to appoint a UK Responsible Person that has a registered place of business in the UK, providing they meet the following criteria:

• is based outside the UK
• does not have a designated authorised representative – who has a registered place of business in Northern Ireland
• is placing devices other than Class I or custom-made devices on the Northern Ireland market

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.

The requirement to appoint a UK Responsible Person will not apply where:

• you are a manufacturer based in Great Britain
• you are a manufacturer based in Northern Ireland
• your Authorised Representative is based in Northern Ireland
• you only intend to place a Class I medical device, custom-made medical device or general IVD on the Northern Ireland market.

Where a Northern Ireland-based Authorised Representative is appointed, the Authorised Representative will need to register all device classes with the MHRA.

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

The Northern Ireland-based Authorised Representative or UK Responsible Person must provide the MHRA details of the person placing the product on the market if they are none of the following:

• manufacturer
• Northern Ireland-based Authorised Representative
• UK Responsible Person

This person, for example, could be an importer.

If you have already registered your device with the MHRA for the purposes of Northern Ireland, it can then be placed on the Great Britain market and will not need to undergo any further registration in Great Britain.

When you must register

There will be a grace period to allow time for compliance with the new registration process. The registration requirements will apply from 1 January 2021, although current registration requirements will continue to apply.

When to register a device on the Great Britain market

Where the manufacturer is in the UK or the Authorised Representative is in Northern Ireland, the following devices should continue to be registered with the MHRA on the same basis as they are now:

• Class I devices
• custom-made devices
• general IVDs

The following devices must be registered with the MHRA from 1 May 2021:

• active implantable medical devices
• Class III medical devices
• Class IIb implantable medical devices
• IVD List A products

The following devices must be registered with the MHRA from 1 September 2021:

• Class IIb non-implantable medical devices
• Class IIa medical devices
• IVD List B products
• self-test IVDs

The following devices must be registered with the MHRA from 1 January 2022 where they have not previously been required to register with the MHRA (manufacturer or Authorised Representative is not based in the UK):

• Class I medical devices
• general IVDs

It will be possible for manufacturers to register devices of different classes that are subject to different grace periods at the same time.

For example, manufacturers (or their UK Responsible Person) will be able to register their Class IIa medical devices at the same time as registering their Class III medical devices. In this case, devices would need to be registered from 1 May 2021 in line with the grace period for registering Class III devices.

Registration for custom-made devices will be in line with the risk class of the device.

If you have already registered your device with the MHRA for the purposes of Northern Ireland, it can then be placed on the Great Britain market and will not need to undergo any further registration in Great Britain.

When to register a device on the Northern Ireland market

Where the manufacturer or the Authorised Representative are based in Northern Ireland, you will not have a grace period for registering the following devices:

• Class I devices
• custom-made devices
• general IVDs

This is because existing registration requirements continue to apply. These devices must continue to be registered from 1 January 2021.

For other device classes there will be grace periods as follows.

These products must be registered from 1 May 2021:

• Class IIIs implantables
• Class IIb implantables
• all active implantable medical devices
• IVD List A products

These products must be registered from 1 September 2021:

• other Class IIb devices
• all Class IIa devices
• IVD List B products
• self-test IVDs

Information required when registering your devices with the MHRA

You will be asked to provide the following type of information when registering your devices with us. Please note these lists are non-exhaustive.

Manufacturer details:

• registered place of business
• company name
• company type e.g. limited company, sole trader
• administrative contact (you can have up to 15 people with access)
• copy of written evidence demonstrating appointment of UK Responsible Persons (where applicable)

Device details:

• which regulations apply
• the class of device you are registering
• Global Medical Devices Nomenclature (GMDN) code and term to describe your device
• 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 Declaration of Conformity, or custom-made statement, as applicable.

If you do not know which GMDN code applies to your device, you will be able to select the relevant description 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.

For a full view of the fields required, go to the Manufacturer and Device and Product and Importer Attributes from 01 Jan 2021 (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, you must provide us with a copy of the instructions for use and the device labelling.

System and procedure packs

You will 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 will 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 for devices that are intended by the manufacturer to be sterilised before use.

Manufacturers of systems and procedure packs are required to:

• register each device type 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

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.

If you are registering devices as a UK Responsible Person or Northern Ireland-based Authorised Representative, you will also need to provide details of the manufacturer(s) you are representing. The above 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 (medical device name, model or version detail) within each application.

This includes updating a registration from a UK Authorised Representative to a UK Responsible Person.

Making changes to your registration

If you are already registered with the MHRA you need to confirm the accuracy of the registered information by the grace periods set out in the ‘When you must register’ section.

If you registered with the MHRA before 1 July 2018 and have a registration number that begins with ‘CA****, or IVD****’ you will need to re-register your details and devices on the DORS system from 1 January 2021.

Please note that we will ask for more detailed information on your devices from 1 January 2021. You will not be able to provide these details until this date.

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

• registered 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 be charged the statutory fee for these changes:

• contact details including email address, telephone numbers
• adding products (medical device name, model or version detail, UDI-DI, for example) to registered devices
• removing devices or products from your registration record

Reference guides

These guides provide instructions on how to use the Device Registration and Certificates of Free Sale System from 1 January 2021:

• Account Management Reference Guide – 1 Jan 2021 (PDF, 1.93MB, 38 pages)
• Device Registration Reference Guide – 1 Jan 2021 (PDF, 3.69MB, 64 pages)

If you are already using our DORS system, please continue to use the existing reference guides until 31 December 2020:

• Account Management Reference Guide (PDF, 1.85MB, 35 pages)
• Device Registration Reference Guide (PDF, 2.97MB, 52 pages)

Video tutorials

These video tutorials will show you an overview of how to use our Device Registration and Certificates of Free Sale System from 1 January 2021.

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

• Registering a general medical device
• Registering an in vitro diagnostic medical device
• Registering a custom-made 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 and deactivate importers
• Manage registered devices
• Adding other addresses (Billing, manufacturing site)
• Upload new Letter of Designation
• Renew registration
• Unregister manufacturer

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
• MHRA reference (account) number
• all the devices registered with us by GMDN term

Manufacturers of in vitro diagnostic medical devices are not published on this database, due to the IVD confidentiality clause (Article 19 of Part IV of the UK MDR 2002).

Contact

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

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.