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, please 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 or UKCA marked 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 intends 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 (the UKCA marking) 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 the MHRA before 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

• Currently, CE marked medical devices with a valid CE marking can be placed on the Great Britain market until 30 June 2023. A valid CE marking is a CE marking that enables the medical device to be placed on the EU market. However, subject to Parliamentary approval, we intend to introduce legislation before 30 June 2023 which will continueprovide 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 recognisedplaced 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 20232030, and
  • certificatesgeneral issuedmedical bydevices EU-recognisedincluding Notifiedcustom-made Bodiesdevices, willcompliant continuewith tothe EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be validplaced foron the Great Britain market up until the sooner of expiry of certificate or 30 June 20232030.

This would enable certain CE marked medical devices to continue to be placed on the Great Britain market for longer.

• 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 the Medical Devices Regulations 2002 (SI (SI 2002 No 618, as amended) (UK (UK MDR 2002) 2002) which, prior to the end of the transition period,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 and UKCA marking 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 (EU MDR) has applied in EU Member States and Northern Ireland. The in vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) (EU (EU IVDR) willhas applyapplied in EU Member States and Northern Ireland fromsince 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 and will not apply in Great Britain.

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

The role of the the MHRA

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

Further guidance is available on how the the MHRA enforces 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) can be found in the MHRA’s 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 the UKCA marking marking and UK Approved Bodies, and guidance on CE marking and Notified Bodies for more information.

Registrations in Great Britain

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The The MHRA will 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 the MHRA.

Where any new registrations or changes to existing registrations are made, a £100 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 the MHRA for 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 provided below.

More information on registrations (including fees) can be found in the the MHRA’s 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 are required to 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.Person. Importers UK Responsible Person requirements for the Northern Ireland market are covered separately below. Importers and distributors are not required to appoint a UK Responsible Person.

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 the MHRA registration registration system, as well as the accounts of any represented manufacturers, willhave bebeen suspended fromas 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.

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 the MHRA before before the devices can be placed on the Great Britain market.

The responsibilities of the UK Responsible Person are set out in the UK UK MDR 2002. 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 the MHRA
• in response to a request from the the MHRA, provide the the MHRA with 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 the MHRA to 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 the MHRA to to provide such samples or access, and communicate to the the MHRA whether whether the manufacturer intends to comply with that request
• cooperate with the the MHRA on 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 the MHRA and, 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 the UKCA marking 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 and UKCA markings. markings.

Importers and distributors

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 the MHRA with with details of device importers. Further guidance on device registrations.

Obligations around storage, transportation and checking device labels for the CE marking or or UKCA marking 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 the UKCA marking. marking.

UKCA mark mark and Conformity Assessment Bodies

UKCA marking

The The UKCA (UK (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 The UKCA marking marking is not recognised in the EU, EU, EEA or or Northern Ireland markets, so relevant products require a CE marking for sale in these markets.

Manufacturers of medical devices can use either the the UKCA marking marking or the CE marking on devices they place on the GBGreat Britain market until 30 June 2023. FromThe 1government Julyintends 2023,to aextend UKCAacceptance markingof willCE bemarked requireddevices in orderGreat toBritain placebeyond a30 deviceJune on2023 as outlined in the Greatsummary Britainabove. market.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,required for UKCA marking, a UK Approved Body is needed. However, manufacturers of non-sterile and non-measuring Class I devices and general general IVDs can can self-certify against the the UKCA marking. marking.

See the guidance Using the the UKCA mark mark for further information.

UKCA marking 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 UK MDR 2002: 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 The MHRA can can designate UK Approved Bodies to conduct conformity assessments against the relevant requirements for the purpose of the the UKCA marking. 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 the UKCA marking, marking, for medical devices, active implantable medical devices and in vitro diagnostic medical devices under Parts II, III, and IV of the UK UK MDR 2002. 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 The MHRA can 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.

Class I medical device and general general IVD manufacturers manufacturers

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

CE marking and Notified Bodies

CE marking

WeUnder willexisting continuelaw, towe will accept CE marked devices on the Great Britain market until 30 June 2023. 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 thatwith havea beenvalid CEcertificate markedand/or declaration of conformity that was issued prior to 26 May 2021)
• Directive 93/42/EEC on medical devices (EU MDD) (for devices thatwith havea beenvalid CEcertificate markedand priordeclaration of conformity that was issued to 26 May 2021)
• Directive 98/79/EC on in vitro diagnostic medical devices (EU IVDD) (for devices thatwith havea beenvalid CEcertificate markedand/or declaration of conformity that was issued prior to 26 May 2022)
• Regulation 2017/745 on medical devices (EU (EU MDR)
• Regulation 2017/746 on in vitro diagnostic medical devices (EU (EU IVDR)

FromPlease 1note Julythat 2023,currently:

• you devicescan thatplace area placedgeneral medical device self-declared to comply with EU MDD requirements on the Great Britain market willif needthe todeclaration conformof withconformity UKCAwas markingmade requirements.

  Inbefore cases26 whereMay you2021 self-certifyand the declaration for that device remains valid for placing it on the CEEU marking,(and NI) market under EU MDR transitional arrangements.

• you willcan beplace ablean toIVD continueself-declared to docomply sowith andEU placeIVDD yourrequirements device on the Great Britain market untilif 30the Junedeclaration 2023.of Pleaseconformity notewas made before 26 May 2022 and the declaration for that youdevice willremains valid for placing it on the EU (and NI) market under EU IVDR transitional arrangements.
• since 26 May 2021, you need to meet EU EU MDR requirements requirements(rather forthan EU MDD requirements) if self-declaring compliance with CE marking Classrequirements Ifor medical devices thatbefore youplacing self-certifythem fromon the Great Britain market.
• since 26 May 2021.2022, Similarly, you will need to meetmeet EU IVDR requirements requirementsif forself-declaring compliance with CE marking ifrequirements youfor self-certify general IVDs before placing them on the Great Britain market. self-

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 26a MayNotified 2022.Body. Such self-declarations include declarations made in relation to system or procedure packs.

RelevantThe government intends to extend acceptance of CE marked medical devices thatin haveGreat beenBritain self-certifiedbeyond against30 theJune CE2023. markingSubject priorto Parliamentary approval, we intend to theseintroduce dateslegislation before 30 June 2023 which will provide that CE marked medical devices may continuebe 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 providingup theiruntil certificatesthe remainsooner validof forexpiry of certificate or 30 June 2028
• IVDs compliant with the EU IVDD can be placed on the Great Britain market underup until the transitionalsooner arrangementsof inexpiry of certificate or 30 June 2030, and
• 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 the sooner of expiry of certificate or 30 June 2030.

ForThis otherwould productenable areascertain coveredCE bymarked medical devices to continue to be placed on the UKCAGreat Britain market for longer. The above timelines will not apply to Class I medical devices and general IVDs marking,under athe UKCAEU directives, where the conformity assessment under the relevant directive and under the EU MDR markingor EU IVDR does not involve a notified body. Similarly, they will benot requiredinclude earliercustom-made thandevices 1that Julyare 2023.compliant Forwith example,the certainEU productMDD areasor listedEU hereAIMDD.

More detail of these transitional arrangements is in the implementation update, willon requirework towards a UKCAstrengthened markingfuture frommedical 1devices January 2023.regime.

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 canwill remainbe able to be placed on the Great Britain market carrying a CE mark untilto 30the Juneabove 2023timelines - irrespective of whether the UK legislation governing the subject matter of that other piece of EU legislation would require a product to have a a UKCA marking marking before 30that Junedeadline. 2023. 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.

Please see guidance for further information 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 until 30 June 2023.market.

Recognition of existing CE certificates for the Great Britain market

UnderCurrently, under the UK UK MDR 2002, 2002, a CE marked device with a valid declaration of conformity or certificate is viewed as meeting the the UKCA marking marking requirements whilst the CE marking continues to be recognised in Great Britain - until 30 June 2023. This includes devices placed on the market that are:

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

As set out above, the government intends 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 the UKCA marking 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 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 the UKCA marking. marking.

Labelling

Registering requirements

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

MedicalIn devicesMarch placed2023, onthe EU revised the GreatEU BritainMDR markettransitional mustarrangements haveto aextend UKCAthe markingvalidity orof aEU MDD and EU AIMDD CE marking,certificates dependingin limited circumstances for certain medical devices. Such certificates can be relied on whichfor legislationplacing thea medical device hason beenthe certifiedNorthern under.Ireland and Great Britain markets until the dates set out in the guidance linked below.

WhereFor relevant,more theinformation numberabout ofthis, and the Approvedsteps Bodyyou orwould Notifiedneed Bodyto musttake alsoto appearrely on an expired CE certificate that has been deemed valid under the label.EU MDR please see the following guidance:

IfGuidance on registering a medical device with an expired certificate that is valid under EU Medical Devices Regulations (EU MDR).

As set out in that guidance, you alreadywill haveneed to complete and upload a validletter CEwith markingthis template.

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

We have prepared guidance on yourregistration device,of youcertain EU MDD Class I medical devices which are nota) requiredreusable surgical instruments or b) upclassified under EU MDR.

The above guidance contains information to re-labelbe aware of if you are registering the following types of medical device with athe UKCAMHRA markingthat untilyou 1have Julyself-declared 2023as formeeting placementrequirements onin theEU GreatMDD:

• EU BritainMDD market.Class DevicesI 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

You can havealso bothfind further information in our medical device registrations guidance .

Labelling requirements

Medical devices placed on the CEGreat andBritain market must have a UKCA marking markingsor presenta CE marking, depending on which legislation the labellingdevice priorhas tobeen 1certified Julyunder.

Where 2023,relevant, andthe dualnumber markingof willthe continueApproved toBody beor acceptedNotified Body must also appear on the Greatlabel.

Devices Britaincan markethave afterboth 1the JulyCE 2023.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 the UKCA marking 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 is required to submit vigilance reports to the the MHRA when 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.

Further information about reporting adverse incidents and corrective actions to the 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).

As set out in its Command Paper on the Northern Ireland Protocol, the UK Government is seeking a new balance to the Protocol. The Government has proposed a full dual regulatory regime for manufactured goods, including medical devices, in Northern Ireland. This guidance will be updated to reflect any changes made to the Protocol.

There is a requirement, in certain cases, to register devices with the MHRA and to have a UK Responsible Person if the manufacturer is based outside the UK, as set out below.

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:

• Since 26 May 2021, the EU EU MDR has has applied in Northern Ireland. The EU EU IVDR has willapplied apply in Northern Ireland fromsince 26 May 20222022.
• 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 assessmentassessment.
• certain medical devices, including in vitro diagnostic medical devices (IVDs), placed on the Northern Ireland market need to be registered with the the MHRA .
• all custom-made devices must be registered with the the MHRA within within 28 days of being made available on the Northern Ireland marketmarket.
• when placing devices on the Northern Ireland market, Great Britain-based manufacturers must appoint an EU or Northern Ireland-based Authorised RepresentativeRepresentative.
• IVD manufacturers based outside the UK may be required to have a UK Responsible Person in place to act as a regulatory point of contact within the UK and comply with the registration requirements.

The EU EU MDR and and EU EU IVDR in 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) willhas applyapplied in Northern Ireland fromsince 26 May 2022.

Please see guidance on the application of thethe EU MDR and EU and IVDR in in Northern Ireland.

CE marking for the Northern Ireland market and implications for UK Approved Bodies

Although the the UKCA marking 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-recognisedEU-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.

UKNI indication

As noted above, for the purposes of the the UKCA marking, 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.

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

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 and UK Responsible Person requirements for Northern Ireland

Certain medical devices, devices, IVDs and and custom-made devices that are placed on the Northern Ireland market need to be registered with the 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 the MHRA’s guidance on registrations for more information.

If you are a non-UK manufacturer placing a IVD on the Northern Ireland market, you may be required to appoint a single UK Responsible Person within the UK. Non-UK manufacturers are not required to appoint a UK Responsible Person for the purpose of placing other devices on the Northern Ireland market.

The requirement to appoint a UK Responsible Person for the purposes of the Northern Ireland market applies in cases where:

• you are a manufacturer based in the EU or the EEA; and

• you place an Annex II device or a device for self-testing on the Northern Ireland market or make available such a device for performance evaluation; OR

• you are a manufacturer based outside the UK, the EU and the EEA; and
• you have an Authorised Representative based outside Northern Ireland; and
• you place an Annex II device or a device for self-testing on the Northern Ireland market or make available such a device for performance evaluation.

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 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 general IVDs with(that theare not for self-testing) with the MHRA.

It is possible for a single entity to act as both an Authorised Representative based in Northern Ireland and a UK Responsible Person.

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

• the manufacturer is based in the EU or or EEA, OR
• the manufacturer is based outside Northern Ireland, the EU or or EEA and and has appointed an EU-based Authorised Representative.

Registration of custom-made devices in Northern Ireland

We have recentlymade introduced legislation to supplement provisions that were introduced in Northern Ireland on 26 May 2021 when the EU Medical Devices Regulation (2017/745) (EU (EU MDR) took effect. This legislation includes a requirement to register all custom-made devices with the the MHRA within 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, NorthernCE Irelandand businessesCE UKNI marked devices that can continuebe toplaced placeon mostthe CENorthern Ireland market and CEare UKNIqualifying markedNorthern devicesIreland ongoods, thecan Greatalso Britainbe marketplaced afteron 30the JuneGreat 2023.Britain market.

In addition, if you are a Northern Ireland-based manufacturer and have already registered your device with the the MHRA for 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 The MHRA is 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 the MHRA.

Placing a medical device on the EU market

CE marking for the EU market

The The UKCA marking 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, youit arehas not ablebeen 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 and UKCA marking 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, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. You can also email devices.regulatory@mhra.gov.uk with questions. 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