Once a medical device has been placed on the UK market, the manufacturer is required to submit vigilance reports to the MHRA when certain incidents occur in the UK that involve their device. They must also take appropriate safety action when required. The manufacturer must ensure their device meets appropriate standards of safety and performance for as long as it is in use.

This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023

The UK Government has guaranteed unfettered access for Northern Ireland’s businesses to the rest of the UK internal market.

There is currently a requirement to register with the MHRA, certain medical devices (including IVDs, custom-made devices and systems or 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 (that are not for self-testing) on the Northern Ireland market in cases where:

The UKNI indication is sometimes referred to as the UK(NI) mark or the UK(NI) marking. These terms refer to the same marking.

Manufacturers of Class I medical devices that are sterile or have a measuring function must use a UK Approved Body to undertake third party conformity assessment in order to affix the UKCA marking and place their devices on the Great Britain market.

The UK Market Conformity Assessment Bodies (UKMCAB) database serves as the UK’s database of conformity assessment bodies. It is the definitive source and a register of UK Government-appointed conformity assessment bodies who can certify goods for the Great Britain market.

Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest. This includes devices placed on the market that:

To place a CE marking on your device for circulation in both Northern Ireland and the EU, you must use an EU-based Notified Body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK Notified Bodies are not recognised within the EU.

As expanded on in the implementation update on work towards a strengthened future medical devices regime, the government has put in place legislation to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.

if you are a medical device manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Responsible Person for all of your devices, who will act on your behalf to carry out specified tasks, such as registration. Further detail on the UK Responsible Person is set out below

Further information about reporting adverse incidents and corrective actions to the MHRA is available for manufacturers of medical devices.

As noted above, for the purposes of the UKCA marking, a UK Approved Body must be used in cases where third party conformity assessment is required. However, for the purposes of the Northern Ireland market, UK-based conformity assessment bodies are referred to as ‘UK Notified Bodies’.

The results of mandatory conformity assessment carried out by UK based conformity assessment bodies are not recognised by the EU. This is the case even if the assessment was carried out before 1 January 2021, unless your product had already been placed on the EU market before 1 January 2021.

For clarity, by ‘self-declarations’ in this section we are referring to cases where, in order to place a medical device on the Great Britain market, manufacturers can rely on self-declarations of compliance with relevant regulatory requirements without certification from a Notified Body. Such self-declarations include declarations made in relation to system or procedure packs.

If you use a UK-based Notified Body to conduct any mandatory third-party conformity assessment for your device, the following will apply:

You do not need to use the UKNI indication if you have self-certified your medical device or have used an EU-recognised Notified Body for mandatory third-party conformity assessment.

The UK Responsible Person acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the Great Britain market.

Therefore, any enforcement or market surveillance powers available in respect of the UKCA marking also apply to CE marked devices placed on the Great Britain market.

This guidance was updated primarily to reflect an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023. This guidance has been updated with changes to ‘Summary of key requirements for placing a device on the Great Britain market’, ‘Registrations in Great Britain’, ‘UKCA marking’, ‘CE marking and Notified Bodies’, ‘Labelling requirements’ and ‘Regulation of medical devices in Northern Ireland’ Reference Guides.

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

UK Notified Bodies that previously had designations under the EU MDD, EU IVDD or EU AIMDD have had their designations rolled over automatically, without having to undergo a new designation process.

Where certificates have been issued by a UK Notified Body and those certificates have not been transferred to an EU Notified Body, the UK Notified Body has been re-designated as a UK Approved Body and will continue to oversee these devices and their manufacturers to ensure continued compliance with the applicable standards of safety and performance under the UKCA marking.

The MHRA can designate UK Approved Bodies to conduct conformity assessments against the relevant requirements for the purpose of the UKCA marking.

The UKCA (UK Conformity Assessed) marking is a UK product marking used for certain goods, including medical devices, being placed on the Great Britain market (England, Wales and Scotland). The UKCA marking is not recognised in the EU, EEA or Northern Ireland markets, so relevant products require a CE marking for sale in these markets.

Certain medical devices, IVDs and custom-made devices that are placed on the Northern Ireland market need to be registered with the MHRA. The precise requirements depend on the location of the manufacturer, the location of the Authorised Representative and the device class, as set out below. Please see the MHRA’s guidance on registrations for more information.

For medical devices, this means that any CE marked device held by a Northern Ireland business is valid for the whole of the UK market provided it falls within the definition of a qualifying “Northern Ireland good”. Therefore, CE and CE UKNI marked devices that can be placed on the Northern Ireland market and are qualifying Northern Ireland goods, can also be placed on the Great Britain market.

The MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside the UK, they must appoint a UK Responsible Person. This UK Responsible Person will then assume certain responsibilities on behalf of the manufacturer as described below in the guidance for UK Responsible Persons, including registering the device with the MHRA.

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.

Any mandatory third-party conformity assessment for the CE marking must be carried out by an EU Notified Body. This includes both EU-based Notified Bodies and Notified Bodies in countries which are listed on the EU’s NANDO Information System.

Devices can have both the CE and UKCA markings present on the labelling. However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked).

The EU Medical Devices Regulation (2017/745) has applied in Northern Ireland since 26 May 2021. The In vitro Diagnostic Medical Device Regulation (2017/746) has applied in Northern Ireland since 26 May 2022.

Since 1 January 2021, there have been a number of changes, introduced through secondary legislation, to how medical devices are placed on the market in Great Britain (England, Wales and Scotland). These are:

Manufacturers of Class I medical devices and general IVDs can self-declare the conformity of their devices against the UK MDR 2002, before affixing a UKCA marking and placing the device on the Great Britain market.

In addition to the CE marking, device manufacturers will also need to apply the UKNI indication if they choose to use a UK Notified Body (should any be designated in future) for mandatory third-party conformity assessment. Device manufacturers must never apply the UKNI indication on its own - it must always accompany a CE marking.

Since 26 May 2021, the EU Medical Devices Regulation (Regulation 2017/745) (EU MDR) has applied in EU Member States and Northern Ireland. The in vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) (EU IVDR) has applied in EU Member States and Northern Ireland since 26 May 2022. As these EU regulations did not take effect during the transition period, they were not EU law automatically retained by the EU (Withdrawal) Act 2018 and therefore do not apply in Great Britain.

Manufacturers must comply with relevant product marking and conformity assessment requirements for medical devices. See below for guidance on the UKCA marking and UK Approved Bodies, and guidance on CE marking and Notified Bodies for more information.

Please note that there are currently no UK Notified Bodies designated to undertake such assessments under the EU MDR or the EU IVDR. This section outlines the criteria for affixing a UKNI marking to devices should any UK Notified Bodies be designated in future.

The MHRA is the Competent Authority for post-market surveillance activity for devices placed on the Northern Ireland market. Where incidents occur in Northern Ireland, these need to be reported to the MHRA.

Under the terms of the Northern Ireland Protocol, the rules for placing medical devices on the Northern Ireland market differ from those applicable to Great Britain (England, Wales and Scotland).

You can place a Class I medical device which has a sterile or measuring function with a valid MDD certificate on the GB market until 30 June 2028.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

Where allowed for in the relevant legislation, you can CE mark your device on the basis of self-certification for the purposes of the Northern Ireland market.

More detail of these transitional arrangements is in the implementation update on work towards a strengthened future medical devices regime.

In cases where the Great Britain importer is not the UK Responsible Person, the importer is required to inform the relevant manufacturer or UK Responsible Person of their intention to import a device. In such cases, the manufacturer or the manufacturer’s UK Responsible Person is required to provide the MHRA with details of device importers. Further guidance on device registrations.

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As set out above in more detail, the government has introduced measures to extend acceptance of CE marked medical devices in Great Britain beyond 30 June 2023.

We have made 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 includes a requirement to register all custom-made devices with the MHRA within 28 days of being made available on the Northern Ireland market.

This guidance only applies to medical devices and does not cover other CE or UKCA marked products, which are subject to separate guidance.

The government has introduced measures that provide that CE marked medical devices may be placed on the Great Britain market to the following timelines:

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 as of 1 January 2022 until the relevant UK Responsible Person has updated their role. For further information on registration requirements, please see guidance on registering medical devices.

Certificates issued by EU-recognised Notified Bodies that are valid for the EU market, will continue to be recognised as valid for the Great Britain market.

Devices are regulated under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) which, prior to the end of the transition period (following the UK’s departure from the EU), gave effect in UK law to the directives listed below:

Where third party conformity assessment is required for UKCA marking, a UK Approved Body is needed. However, manufacturers of non-sterile and non-measuring Class I devices and general IVDs can self-certify against the UKCA marking.

In March 2023, the EU revised the EU MDR transitional arrangements to extend the validity of EU MDD 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.

To place goods on the EU market, manufacturers must use an EU-recognised Notified Body and then affix the CE marking on its own. Goods bearing the combined “CE & UKNI” marking will not be accepted on the EU market. If a device manufacturer uses an EU-recognised Notified Body for mandatory third-party conformity assessment, the CE marking on its own is sufficient to place a device on the Northern Ireland market.

Where allowed for under the relevant legislation, you can CE mark your medical device on the basis of self-certification for the purposes of the EU market.

Although the UKCA marking is available for use in Great Britain, a CE marking is needed for devices placed on the Northern Ireland market and EU rules need to be met.

There is further information below on how devices that have already been registered with the MHRA under the EU MDR or the EU IVDR are regulated.

In addition, if you are a Northern Ireland-based manufacturer and have already registered your device with the MHRA for the purposes of Northern Ireland, it can be placed on the Great Britain market and will not need to undergo any further registration in Great Britain.

All medical devices, including IVDs, custom-made devices and systems or procedure packs must be registered with the MHRA before being placed on the Great Britain market. In Great Britain (England, Wales and Scotland), devices will be required to conform to the UK MDR 2002, with transitional arrangements for acceptance of CE marked medical devices as set out above, in order to be registered with the MHRA.

We will accept CE marked devices on the Great Britain market until, at the latest, 30 June 2030 depending on device type and classification. This applies to devices that have been CE marked under and fully conform with the following applicable EU legislation:

As noted above, to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person.

You can also download an infographic of the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023.

For the purposes of the Great Britain market, UK Approved Bodies can conduct conformity assessments in relation to the UKCA marking, for medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002. UK Approved Bodies are not able to conduct conformity assessments in relation to the CE marking.

The government has put in place legislation to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023 as outlined in the summary above. For more detail of these transitional arrangements see the implementation update on work towards a strengthened future medical devices regime.

The responsibilities of the UK Responsible Person are set out in the UK MDR 2002. In summary, in addition to the above registration requirements, the UK Responsible Person must:

This guidance was updated to reflect changes to medical device regulatory requirements that will take effect on 1 January 2022.

Medical devices placed on the Great Britain market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under.

Great Britain-based Authorised Representatives are no longer recognised in the EU. This means that they are not able to carry out tasks on the manufacturer’s behalf for the purposes of placing devices on the EU market.

You must ensure that your device meets EU labelling requirements in order to place it on the EU market. Both the CE marking and UKCA marking can be placed on a product so long as neither impedes the visibility of the other and both marking requirements are met. Devices placed on the Northern Ireland market must meet EU labelling requirements.

Manufacturers of medical devices can use either the UKCA marking or the CE marking on devices they place on the Great Britain market until 30 June 2023. The government has introduced measures to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023 as outlined in the summary above. For more detail of these transitional arrangements see the implementation update on work towards a strengthened future medical devices regime.

See our medical device registrations guidance for information to be aware of if you are registering the following types of medical device with the MHRA that you have self-declared as meeting requirements in EU MDD:

The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.

Obligations around storage, transportation and checking device labels for the CE marking or UKCA marking also apply. The importer or distributor’s name and address do not need to be present on the label unless the importer or distributor are acting as the UK Responsible Person for the purposes of the UKCA marking.

For more information about this, and the steps you would need to take to rely on an expired CE certificate that has been deemed valid under the EU MDR please see our medical device registrations guidance.

Where medical devices are subject to the requirements of any of the medical devices legislation cited above and, in order to be CE marked, must also meet the relevant requirements of another piece of EU legislation (such as the Directive restricting the use of certain hazardous substances), we intend that they will be able to be placed on the Great Britain market carrying a CE mark to the above timelines - irrespective of whether the UK legislation governing the subject matter of that other piece of EU legislation would require a product to have a UKCA marking before that deadline. In order to maintain the use of the CE marking for a medical device in Great Britain, the manufacturer will need to meet all relevant EU legislation that governs their device.

Where a manufacturer is not established in the UK, they must appoint a UK Responsible Person to register and act on their behalf. See guidance on UK Responsible Persons below for more information.

The above timelines will not apply to Class I medical devices and general IVDs under the EU directives, where the conformity assessment under the relevant directive and under the EU MDR or EU IVDR does not involve a notified body. Similarly, they will not include custom-made devices that are compliant with the EU MDD or EU AIMDD.

The MHRA performs market surveillance of medical devices on the UK market and is able to take decisions over the marketing and supply of devices in the UK.

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, contact your Trade Association by emailing:

Where any new registrations or changes to existing registrations are made, a £240 standard fee will apply per application.

This means that the current Great Britain route to market and UKCA marking requirements are based on the requirements derived from the above EU legislation.

UKCA marking requirements are currently based on the requirements of the relevant Annexes to the Directives listed below, which have been modified by Schedule 2A to the UK MDR 2002:

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UK Notified Bodies can apply to be designated under the relevant EU legislation for the purposes of conducting conformity assessments for the Northern Ireland market.

Great Britain manufacturers are required to 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 an EU-based Authorised Representative is appointed, the Great Britain-based manufacturer needs to register all device classes other than Class I devices and general IVDs (that are not for self-testing) with the MHRA.

This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods.

We are reviewing our position on acceptance of EU MDR and EU IVDR CE certificates renewed after a strengthened future regime for medical devices is in place, taking on board stakeholder feedback. We will publish an update on this in due course. Please note that existing legislation does not prevent reliance on renewed EU MDR and EU IVDR certificates for placing medical devices on the GB market until 30 June 2030.

If you are a manufacturer based in Great Britain or another country outside the EU, you must appoint an Authorised Representative based in the EU or Northern Ireland if you wish to supply devices to the EU market.

The name and address of the UK Responsible Person, where applicable, must be included on the product labelling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed. UK Responsible Person details do not need to be included on labelling for CE marked devices, unless the device bears both the CE and UKCA markings.

Manufacturers wishing to place a device on the Great Britain market need to register with the MHRA. More information on registrations (including fees) can be found in the MHRA’s registrations guidance.

The MHRA can designate UK Notified Bodies for the purposes of conducting conformity assessment for the combined CE and UKNI marking, which is valid on the Northern Ireland market. Please see the Northern Ireland guidance below for further information.

The UKCA marking is not recognised on the EU market. To place a device on the EU market you must adhere to the relevant EU legislation and affix a CE mark to demonstrate compliance.

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