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Guidance: Register medical devices to place on the market

Medicines Healthcare Products Regulatory Agency

January 9
13:09 2024

All medical devices, includingIVDs, custom-made devices and systems or procedure packs, must be registered with theMHRAbefore 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) (UKMDR2002) as they apply in Great Britain so that they can be placed on the market and registered with theMHRA.

Registration requirements differ for Northern Ireland.

TheMHRAwill 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).

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

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

Therefore, you are not permitted to make any claims to this effect, including the use of anyMHRAlogos 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 please 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 theMHRA, 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 UKMDR2002 that you inform theMHRAbefore 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
  • IVDsyou have manufactured
  • IVDsundergoing 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 theMHRAregistration 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.

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

Where any changes to registrations are made, a statutory fee will apply per application.

Distributors and suppliers are not required to register with theMHRA.

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 theMHRAwith 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 UKMDR2002 that you inform theMHRAwhen 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

Non-UK manufacturers are not required to appoint a UK Responsible Person for the purpose of placing medical devices 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.

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 generalIVDs (that are not for self-testing)with theMHRA.

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

Please note that new requirements have 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 theMHRA.

Registration of importers

The Northern Ireland-based Authorised Representative must provide theMHRAwith 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.

Registration of custom-made devices in Northern Ireland

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

Only custom-made devices consistent with EU MDR 2017/745 can be placed on the EU market (including Northern Ireland).

Custom-made devices registered under the EU MDD or EU AIMDD and placed on the market in an EU member state other than Northern Ireland, prior to 26 May 2021, can still be registered with MHRA for the purposes of placing on the NI market only.

When you must register

When to register a device on the Great Britain market

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

Custom-made devices under the EU Medical Devices Directive (EU MDD) (93/42/EEC) or EU Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC) can no longer be placed on the GB market. Please 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 and EU AIMDD requirements) for the GB market only, with a suitable accompanying custom-made statement.

Since 1 January 2021, there have been requirements for non-UK manufacturers to have a UK Responsible Person for the purposes of registering devices placed on the Great Britain market. A Northern Ireland-based Authorised Representative can no longer register devices on a manufacturers 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 theMHRA, certain medical devices (includingIVDs, custom-made devices and systems and procedure packs) that are placed on the Northern Ireland market.

Only custom-made devices consistent with EU MDR 2017/745 can be placed on the EU market (including Northern Ireland).

Custom-made devices registered under the EU MDD or EU AIMDD and placed

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