Regulating medical devices in the UK

Overview

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

This guidance provides information on the UK system, including for:

• getting your device certified
• conformity marking your device
• registering your 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.

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, see Regulation of medical devices in Northern Ireland below.

In this guidance, ‘medical device’ includes in vitro diagnostic medical devices and active implantable medical devices.

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

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.

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.

Summary of key requirements for placing a device on the Great Britain market

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:

• a new route to market and product marking (the UKCA marking) is available for manufacturers wishing to place medical devices on the Great Britain market
• all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices and systems or procedure packs, need to be registered with the MHRA before they are placed on the Great Britain market
• 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)
• a valid CE mark is a CE marking that enables the medical device to be placed on the EU market; the government has introduced measures which provide that CE-marked medical devices may be placed on the Great Britain market to the following timelines:
  • general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
  • in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030
  • general medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030
• the EU no longer recognises UK notified bodies
• UK notified bodies are not able to issue CE certificates - and have become UK approved bodies

Legislation that applies in Great Britain

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:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

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.

The EU Medical Devices Regulation and EU in vitro Diagnostic Medical Devices Regulation

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.

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.

The role of the MHRA

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.

The MHRA is responsible for the designation and monitoring of UK conformity assessment bodies.

Further guidance is available on how the MHRA enforces the legislation on medical devices.

Requirements for those manufacturing and supplying devices in Great Britain

Manufacturers wishing to place a device on the Great Britain market need to register with the MHRA. More information on registrations (including fees) is available in the MHRA registrations guidance.

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.

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.

Registrations in Great Britain

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.

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.

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.

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

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

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.

Further information on registration requirements for Northern Ireland is available below.

More information on registrations (including fees) is available in the MHRA registrations guidance.

UK responsible person

As noted above, to place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK must appoint a UK responsible person.

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 do not need to appoint a UK responsible person.

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, see guidance on registering medical devices.

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.

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:

• ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
• keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
• in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
• where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
• where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
• cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
• immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed
• if the manufacturer acts contrary to its obligations under these regulations:
  • terminate the legal relationship with the manufacturer; and
  • inform the MHRA and, if applicable, the relevant approved body of that termination

There is nothing to prevent an importer or distributor from also acting as a UK responsible person.

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.

Importers and distributors

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 manufacturer or the manufacturer’s UK responsible person must provide the MHRA with details of device importers. See further guidance on device registrations.

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.

UKCA mark and conformity assessment bodies

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.

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.

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.

See the guidance Using the UKCA mark for further information.

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:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD)
• Directive 93/42/EEC on medical devices (EU MDD)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD)

UK approved bodies

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

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.

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 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.

See the guidance on conformity assessment bodies for further information.

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. See the Northern Ireland guidance below for further information.

Class I medical device and general IVD manufacturers

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.

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.

CE marking and notified bodies

CE marking

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:

• Directive 90/385/EEC on active implantable medical devices (EU AIMDD) (for devices with a valid certificate and/or declaration of conformity that was issued prior to 26 May 2021)
• Directive 93/42/EEC on medical devices (EU MDD) (for devices with a valid certificate and declaration of conformity that was issued to 26 May 2021)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) (for devices with a valid certificate and/or declaration of conformity that was issued prior to 26 May 2022)
• Regulation 2017/745 on medical devices (EU MDR)
• Regulation 2017/746 on in vitro diagnostic medical devices (EU IVDR)

Note that currently:

• you can place a general medical device self-declared to comply with EU MDD requirements on the Great Britain market if the declaration of conformity was made before 26 May 2021 and the declaration for that device remains valid for placing it on the EU (and NI) market under EU MDR transitional arrangements
• you can place an IVD self-declared to comply with EU IVDD requirements on the Great Britain market if the declaration of conformity was made before 26 May 2022 and the declaration for that device remains valid for placing it on the EU (and NI) market under EU IVDR transitional arrangements
• since 26 May 2021, you need to meet EU MDR requirements (rather than EU MDD requirements) if self-declaring compliance with CE marking requirements for medical devices before placing them on the Great Britain market
• since 26 May 2022, you need to meet EU IVDR requirements (rather than EU IVDD requirements) if self-declaring compliance with CE marking requirements for IVDs before placing them on the Great Britain marketmarket.

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.

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

• general medical devices compliant with the EU MDD or EU AIMDD can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
• IVDs compliant with the EU IVDD can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030
• general medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until 30 June 2030

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.

You can place self-declared CE-marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

• self-declared against EU MDR requirements (until 30 June 2030), or
• self-declared against MDD requirements before 26 May 2021 where notified body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028) - this includes upclassified devices and reusable surgical instruments

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.

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

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.

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.

For further information, see guidance on using the UKCA marking for other types of product.

EU notified bodies

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.

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.

Recognition of CE certificates for the Great Britain market

Currently, under the UK MDR 2002, the government views a CE-marked device with a valid certificate as meeting the UKCA marking requirements while 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:

• were CE marked in accordance with the EU MDD or EU AIMDD (before 26 May 2021), or in accordance with the EU IVDD (prior to 26 May 2022)
• are CE marked in accordance with the EU MDR or EU IVDR

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.

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.

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 redesignated 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.

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.

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.

Registering medical devices that have an expired CE certificate that is valid under EU MDR Article 120

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.

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, see our medical device registrations guidance.

Registering medical devices which the EU MDR upclassifies from Class I and that are EU MDD Class I reusable surgical instruments

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:

• EU MDD Class I reusable surgical instruments that would require notified body involvement in their assessment under EU MDR
• EU MDD Class I medical devices that are upclassified under and require notified body involvement pursuant to the EU MDR

Registering IVD devices that have an expired/expiring CE certificate that is valid under EU IVDR 

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. Such certificates can be relied on for placing an 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 CE certificate that has been deemed valid under the EU IVDR Article 110  please see our IVD device registration guidance. 

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

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

• EU IVDD General IVD devices that are upclassified to either a Class B, C, or D IVD device and would require Notified Body involvement in their assessment under EU IVDR.

Labelling requirements

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.

Where relevant, the number of the approved body or notified body must also appear on the label.

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).

Post-market surveillance and vigilance

Once a medical device has been placed on the UK market, the manufacturer must 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.

In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. These measures will come into force on 16 June 2025 and will facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed supporting better risk management and containment of safety issues reducing harm.

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

Regulation of medical devices in Northern Ireland

Overview

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).

Summary of key requirements for placing a device on the Northern Ireland market

The following requirements apply to manufacturers wishing to place medical devices on the Northern Ireland market:

• the EU MDR has applied in Northern Ireland since 26 May 2021
• the EU IVDR has applied in Northern Ireland since 26 May 2022
• CE marking is required for the Northern Ireland market (in addition, the UKNI indication is required if a UK notified body undertakes mandatory third-party conformity assessment)
• certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market need to be registered with the MHRA
• all custom-made devices must be registered with the MHRA within 28 days of being made available on the Northern Ireland market
• when placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based authorised representative

The EU MDR and EU IVDR in Northern Ireland

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.

See our guidance on the application of the EU MDR and EU IVDR in Northern Ireland.

CE marking for the Northern Ireland market and implications for UK approved bodies

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.

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.

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 EU does not recognise the results of conformity assessments carried out by UK notified bodies.

UKNI indication

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’.

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.

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 if any UK notified bodies are designated in future.

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 (if any are 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.

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.

In summary, you need to use the UKNI indication if:

• you are placing medical devices on the Northern Ireland market, and
• your medical devices require mandatory third-party conformity assessment, and
• you use a UK notified body to carry out those conformity assessments

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

Further guidance on applying the UKNI marking.

Registration requirements for Northern Ireland

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. See the MHRA guidance on registrations for more information.

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 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.

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

Registration of custom-made devices in Northern Ireland

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.

Unfettered access provisions

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

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.

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.

Post-market surveillance and vigilance

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 must be reported to the MHRA.

See guidance on the application of the EU MDR and EU IVDR in Northern Ireland.

Placing a medical device on the EU market

CE marking for the EU market

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

• if your device was placed on the EU market before 1 January 2021, in accordance with the terms of the Withdrawal Agreement, it may remain on the EU market
• from 1 January 2021, it has not been possible to place a device requiring third party conformity assessment on the EU market unless it has been assessed by an EU-recognised notified body

Conformity assessment

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.

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.

Authorised representatives

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.

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.

Labelling requirements

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.

Contact us

For further information, contact our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000.

Alternatively, contact your Trade Association by emailing:

• Association of British HealthTech Industries (ABHI): enquiries@abhi.org.uk
• British In Vitro Diagnostics Association (BIVDA): enquiries@bivda.org.uk
• Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk
• The British Healthcare Trades Association (BHTA): info@bhta.com
• UK Responsible Persons Association (UKRPA): enquiries@ukrp-association.org
• British Dental Industry Association (BDIA): info@bdia.org.uk