Regulating Medical Devices in the UK
What’s needed to place a medical device on the market in Great Britain, Northern Ireland, and the EU
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market. Under the Northern Ireland Protocol, Northern Ireland has different rules from Great Britain.
In this paper, we’ll set out what you need to know and highlight the differences depending on where you’re based and which market(s) you sell on.
Key Requirements for Great Britain (England, Wales, and Scotland)
There are some key requirements for placing a device on the market in Great Britain. Since 1 January 2021, secondary legislation in Great Britain has changed how medical devices are placed on the market.
- UKCA marking has been introduced for manufacturers placing devices on the Great Britain market.
- Before being sold in Britain, all medical devices, including IVDs, custom-made devices, systems, and procedure packs, must be registered with the MHRA.
- If you are outside the UK and want to sell a device in Great Britain you must appoint a UK Responsible Person. They must act on your behalf to perform responsibilities such as registration.
- CE marking and certificates from EU-recognized Notified Bodies will be valid in Great Britain until 30 June 2023.
- The EU no longer recognises UK Notified Bodies.
- UK Notified Bodies have changed to UK Approved Bodies. They cannot provide CE certificates.
Applicable legislation in Great Britain
Before the transition period ended, the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) gave effect in UK law to the directives listed below:
- Directive 90/385/EECon active implantable medical devices (EU AIMDD)
- Directive 93/42/EECon medical devices (EU MDD)
- Directive 98/79/ECon in vitro diagnostic medical devices (EU IVDD)
This means that the Great Britain route to market UKCA marking requirements is based on the above EU legislation.
Since 26 May 2021, the EU MDR (Regulation 2017/745) has applied in EU Member States and Northern Ireland. The EU IVDR (Regulation 2017/746) (EU IVDR) applies in EU Member States and Northern Ireland from 26 May 2022. These EU regulations did not take effect during the transition period, thus the EU (Withdrawal) Act 2018 did not automatically retain them and does not apply in Great Britain.
Great Britain – manufacturing, supply, and registrations
The MHRA performs market surveillance of medical devices on the UK market and regulates the marketing and supply of devices in the UK. MHRA also designates and monitors UK conformity assessment bodies. All medical device manufacturers must comply with product marking and conformity assessment requirements.
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, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with the MHRA.
In addition, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the Great Britain market until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.
The MHRA only accepts registration of devices from UK. Non-UK manufacturers must appoint a UK Responsible Person. This UK Responsible Person assumes certain responsibilities on the manufacturer’s behalf, including registration with the MHRA.
Manufacturers based in Northern Ireland that have already registered a device with the MHRA for the purposes of the Northern Ireland market, can then place the device on the Great Britain market and will not need to undergo any further registration in Great Britain.
UK Responsible Person (UKRP)
The UK Responsible Person (UKRP) performs certain tasks on the behalf of the non-UK manufacturer to meet the manufacturer’s obligations. The manufacturer must provide the UKRP with written evidence of authority to act on their behalf.
UK MDR 2002 sets out the responsibilities of the UKRP. In addition to the above registration requirements, the UK Responsible Person must:
- Ensure that the declaration of conformity, technical documentation, and manufacturer conformity assessment procedure been carried out by the manufacturer.
- Retain a copy of the technical documentation, declaration of conformity, and relevant certification (including any amendments and supplements) for MHRA inspection.
- Provide the MHRA with all the information and documentation necessary to demonstrate device conformity upon request.
- Comply with the MHRA’s request to provide device samples or access to the device where possible.
- If neither device sample or access is possible, communicate any MHRA request to the manufacturer to provide such samples or access. They must also communicate to the MHRA whether the manufacturer intends to comply.
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users regarding suspected device related incidents.
- If the manufacturer acts contrary to its obligations under these Regulations they must terminate the legal relationship with the manufacturer; and inform the MHRA and, if applicable, the relevant Approved Body of that termination.
Importers and Distributors
Importers and distributors are not required to appoint a UKRP. However, there is nothing to prevent an importer or distributor from also acting as a UKRP.
The Importer must inform the relevant manufacturer or UKRP of their intention to import a device. The manufacturer or UKRP must provide MHRA with importer details.
There are also obligations for storage, transportation and checking device labels for CE or UKCA marking. Unless acting as the UKRP, the importer/distributor details don’t need to be on the device label.
UKCA mark and Conformity Assessment Bodies
The UK Conformity Assessed (UKCA) markings are used for medical devices and other goods sold in Great Britain. The EU, EEA, and Northern Ireland markets don’t recognise the UKCA certification, hence products sold on those markets need a CE marking.
Medical device manufacturers in GB can use either the UKCA or CE designation until 30 June 2023. Devices sold in Great Britain must have a UKCA marking from 1 July 2023.
UK Approved Bodies can conduct UKCA marking conformity assessments for the MHRA. UK Notified Bodies holding EU MDD, EU IVDD, or EU AIMDD designations were automatically rolled over. They can conduct UKCA conformity assessments for medical devices, active implantable medical devices, and in vitro diagnostic medical devices under Parts II, III, and IV of the UK MDR 2002 for the UK market. UK Approved Bodies cannot assess CE conformity.
Third-party conformity assessment requires a UK Approved Body. Non-sterile, non-measuring Class I devices and general IVD manufacturers can self-certify against the UKCA marking. However, manufacturers must use a UK Approved Body for third-party conformity assessment to get the UKCA marking and sell their devices in Great Britain.
CE marking and Notified Bodies
CE marked devices will be accepted on the Great Britain market until 30 June 2023. This includes self-certified CE marking that meet EU MDR/IVDR requirements.
CE marked devices that were self-certified prior to the implementation of the EU MDR/IVDR may continue to be placed on the Great Britain market. However, their certificates must remain valid for the EU market under the transitional arrangements in the EU MDR/IVDR.
Medical devices that meet the requirements of any of the legislation cited above and another piece of EU medical device legislation (such as the Directive restricting the use of certain hazardous substances) can remain on the Great Britain market with a CE mark until 30 June 2023. A manufacturer in Great Britain must comply with all EU regulations to use the CE marking.
Certificates issued by EU-recognised Notified Bodies for the EU market will remain valid for Great Britain until 30 June 2023.
Under UK MDR 2002, a CE-marked device with a valid declaration of conformity or certificate meets UKCA marking requirements 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 MDR or EU IVDR
So, UKCA enforcement and market monitoring powers apply to CE-marked devices sold in Great Britain.
The UK Notified Body has been renamed a UK Approved Body. It will continue to oversee devices and their manufacturers to ensure compliance with the UKCA marking’s safety and performance standards.
Labelling requirements
Where relevant, the number of the Approved Body or Notified Body must appear on the label.
If your device has a valid CE marking, you do not need to re-label it with a UKCA marking until 1 July 2023 for the Great Britain market. Dual marking of both CE and UKCA marks will continue to be accepted on the Great Britain market after 1 July 2023. However, the name and address of the UK Responsible Person, where applicable, must be included on product labelling or 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
A manufacturer with device(s) on the UK market must submit vigilance reports to the MHRA when certain incidents involve their device. The manufacturer must also take appropriate safety action when required. It is the manufacturer’s responsibility to ensure their device meets safety and performance standards throughout use.
Regulation of medical devices in Northern Ireland
The Northern Ireland Protocol differs from Great Britain’s medical device market rules. The Government has changed the NI Protocol with new legislation. However, you should continue to use the guidance below for now.
In certain situations, devices must be registered with the MHRA and have a UK Responsible Person if the producer is based outside the UK.
Key requirements for Northern Ireland
There are some key requirements for placing a device on the market in Northern Ireland:
- The EU MDR has applied in Northern Ireland since 26 May 2021. The EU IVDR has applied since 26 May 2022.
- Northern Ireland requires CE marking. UK Notified Bodies conducting mandatory third party conformity assessment must also indicate UKNI.
- In Northern Ireland, the MHRA must register certain medical devices, including IVDs.
- Custom made devices sold in Northern Ireland must be MHRA registered within 28 days of going to market.
- Manufacturers in Great Britain selling devices in Northern Ireland must appoint an EU or Northern Ireland based Authorised Representative.
- IVD manufacturers based outside the UK may require a UK Responsible Person to act as a regulatory point of contact and meet comply with registration requirements.
CE marking and implications for UK Approved Bodies
UKCA marking is available for use in Great Britain. Devices sold in Northern Ireland must have a CE marking and comply with EU regulations. For the Northern Ireland market, you can CE mark your device through self-certification if allowed for in the relevant legislation.
An EU-recognised Notified Body must conduct any mandatory third-party conformity assessment to CE mark your device for circulation in Northern Ireland and the EU. The EU doesn’t recognise UK Notified Bodies’ conformity assessments.
UKNI indication
Third-party conformity assessment requires a UK Approved Body for UKCA marking. UK conformity assessment bodies are called “UK Notified Bodies” for the Northern Ireland market. UK Notified Bodies can apply under EU regulations to conduct conformity assessments for the Northern Ireland market.
If a manufacturer chooses a UK Notified Body for mandatory third-party conformity assessment, the manufacturers must also apply the UKNI indication. Device manufacturers must combine the UKNI indication with a CE marking. Manufacturers shouldn’t use the UKNI on its own.
Manufacturers must use an EU-recognised Notified Body and CE mark their products to sell in the EU. EU markets will not accept goods marked “CE & UKNI.” If a manufacturer uses an EU-recognised Notified Body for mandatory third-party conformity assessment, the CE marking alone is enough to sell a product in Northern Ireland.
To summarise, the UKNI indicator is required 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.
Note: The UKNI indication is sometimes referred to as the UK(NI) mark or the UK(NI) marking. These terms refer to the same marking.
Registration and UK Responsible Person requirements for Northern Ireland
Medical, IVD, and custom-made equipment sold in Northern Ireland must be MHRA-registered. The device class, manufacturer location, and Authorised Representative location determine the exact requirements.
Non-UK manufacturers selling IVDs in Northern Ireland may need to appoint a UK Responsible Person. Non-UK manufacturers can sell other devices in Northern Ireland without a UK Responsible Person.
The Northern Ireland market requires a UK Responsible Person if:
- 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 must appoint an EU or Northern Ireland-based Authorised Representative to sell devices in Northern Ireland. A Northern Ireland-based Authorised Representative must register all device classes with the MHRA. When an EU-based Authorised Representative is appointed, the Great Britain manufacturer must register all device classes except Class I and general IVDs with the MHRA.
One entity can be a UK Responsible Person and a Northern Ireland Authorised Representative.
IVDs, custom-made devices, systems, and procedure packs sold in Northern Ireland must be registered with the MHRA. Manufacturers selling Class I medical devices or general IVDs in Northern Ireland are exempt from this requirement 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.
Unfettered access provisions
The UK Government has guaranteed unfettered access for Northern Ireland’s businesses to the rest of the UK internal market.
This means that any CE-marked medical device held by a Northern Ireland business is valid for the entire UK market if it qualifies as a “Northern Ireland good.” Thus, Northern Ireland companies can sell most CE and CE UKNI-marked devices in Great Britain beyond 30 June 2023.
If you are a Northern Ireland manufacturer and have registered your device with the MHRA for Northern Ireland, it can be sold in Great Britain without further registration.
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 need to be reported to the MHRA.
Placing a medical device on the EU market
CE marking for the EU market
The UKCA marking is not recognised on the EU market. Manufacturers require a CE mark to sell a device in the EU.
If you use a UK-based Notified Body for mandatory third-party conformity assessment of your device, the following applies:
- If your device was on the EU market before 1 January 2021, the Withdrawal Agreement allows it to stay.
- From 1 January 2021, devices must be examined by an EU-recognised Notified Body before being sold in the EU.
Conformity assessment
The EU does not recognise UK-based mandatory conformity assessment results. Unless your product was already on the EU market before 1 January 2021, this applies even if the assessment was done before that date.
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
The EU no longer recognises Great Britain Authorised Representatives. They cannot perform manufacturer-requested activities for device placement on the EU market.
If you’re a Great Britain or non-EU manufacturer selling devices in the EU, you must appoint an Authorised Representative in the EU or Northern Ireland.
Labelling requirements
To sell in the EU, your device must meet labelling requirements. A product can have both the CE and UKCA markings if neither obscures the other and both marking requirements are met. Northern Ireland devices must be EU-labelled.
CLIN-r+ Recommendations
Selling medical devices in the UK differs greatly from selling them in the EU, but both are subject to a lot of changes going forward.
Manufacturers should consider professional assistance to support you with the transition to ensure that all requirements are met. With the help of your internal team, Clin-r+ can create a gap analysis of your current CE submission and transfer overlapping data to create an updated technical file that meets the correct criteria.
If you’d like to know more about selling medical devices in the UK, we can provide professional assistance and clarify any issues. CLIN-r+ has a wealth of experience to call upon. Get in touch!
