Bruce McGill, Vice President of Global Certification, Intertek07.15.21
The United Kingdom’s official withdrawal from the European Union at the start of the year (aka “Brexit”) changed the economic markets in the region, with the UK and EU each having their own regulatory framework impacting conformity assessment, product marking, and market access. Brexit impacted multiple industries, and the medical device industry was not spared. The UK government has introduced several key changes through secondary legislation for medical devicesplacedonthemarketin GreatBritain(England,Wales,andScotland). These requirements, overseen by the Medicines and Healthcare Products Regulatory Agency (MHRA), ensure medicines and medical devices work and are acceptably safe.
1. UK Legislation & Directives
By withdrawing from the EU, the UK government removed itself from EU Directives and Regulations that are important considerations for medical device development, testing, certification, and production. Applicable legislation for medical devices in the UK is based on EU legislation in place as of the first of January 2021. However, changes made to EU legislation after that point will not necessarily translate to the UK.
Under the UK Medical Devices Regulations of 2002, the following medical device legislation is in effect for Great Britain:
Manufacturers will need to demonstrate that medical device meets these requirements by carrying out product conformity assessments. This will vary based upon the device’s classification, per the applicable legislation. That is to say a general medical device, which must adhere to Directive 93/42/EEC, will be assessed/evaluated differently than an active implantable medical device or in-vitro diagnostic device, which must be tested to their specific standards.
It may also be possible to use an international standard designated to the UK MDR 2002. Examples include (but are not limited to) ISO 13485, which applies to quality management systems for medical device manufacturers, and ISO 14971, covering medical device risk management. Other process-specific standards may also be covered by the UK MDR 2002, like those related to sterilization. Products that comply with the designated standards will conform with the relevant parts of the UK directive covered by these standards.
There are also standards specific to individual types of medical devices or to certain considerations for medical electrical devices and equipment, such as electromagnetic compatibility (EMC). Compliance to applicable standards is illustrated through marking and labelling, which is granted by a UK approved body (AB). For medical devices, ABs are organizations designated by the MHRA to assess whether manufacturers and their medical devices meet requirements set out in the Medical Device Regulations 2002. Marking and labelling requirements for the UK have been modified with Brexit.
2. Marking & Labelling
Currently, CE marking is recognized in Great Britain, and will continue to be until June 30, 2023, for products already on the market. Likewise, certificates issued by EU-recognized notified bodies (NBs) will continue to be valid for the Great Britain market until the same date. However, the EU no longer recognizes UK ABs, meaning these organizations are unable to issue CE certificates unless they are jointly an EU NB and UK AB, which some labs have opted to do—particularly for the Northern Ireland market. And, as of July 1, 2023 CE marking will no longer be accepted in England, Scotland, or Wales. Instead, a new route to market and product marking is available for manufacturers wishing to place a device on the market in Great Britain: the UK Conformity Assessed (UKCA) mark.
The UKCA mark is the new product mark for certain goods place on the market in England, Wales, and Scotland. It applies to most goods that previously required CE marking, including medical devices. UKCA marking went into effect in January 2021. In some circumstances, UKCA marking is required immediately for certain items, such as newly designed products yet to be placed on the market. Those same products will require CE marking for the EU. Until 2023, goods must affix the UKCA on a label, to the product, or an accompanying product. After the first of January in that year, UKCA marking must be affixed directly to the products.
UKCA marking can only be placed on a product (or label) by the manufacturer or an authorized representative, where specified by legislation. The manufacturer takes full responsibility for the product’s conformity with requirements of the relevant legislation. UKCA marking illustrates compliance with UK legislation only. Markings that may misconstrue the meaning or form of the UKCA marking cannot be used. The mark’s proportions cannot be changed, and it must be at least 5 mm in height. It must be easily visible, legible, and as of 2023, permanent. Where relevant, the number of the Notified Body or Approved Body must also appear on the label.
Manufacturers with a valid CE marking on their device aren’t required to relabel the device with a UKCA mark until 1 July 2023. Devices can have both marks present on the labelling prior to 1 July 2023, and dual marking 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 where the UKCA mark has been affixed (including when devices have been dual marked).
Just as the EU does not recognize UK ABs, they will also not recognize the UKCA mark. Products intended for both the UK and EU markets can be marked with both CE and UKCA markings, provided they are fully compliant with applicable regulations, and so long as neither impedes the visibility of the other. Manufacturers should work with their certification partner to have products evaluated and marked for both certification schemes.
In Northern Ireland, the CE mark will be accepted on products, provided they come from an EU conformity assessment body. If manufacturers choose to use a UK AB for conformity assessments for products requiring an assessment, they must apply a UKNI mark in addition to the CE mark for this region. The UKNI mark must accompany the CE conformity mark; it can never appear on a product alone and should only appear on products with specific legislation requiring it. It must be applied to the product itself or the packaging, with the possibility to feature it in manuals or supporting documents in some cases. The UKNI mark applies to and is valid in Northern Ireland only. To place goods on the EU market, manufacturers must use the CE marking on its own without the UKNI mark. Devices bearing both the CE and UKNI marks will not be accepted on the EU market.
3. Device Registration
As of January 1, all medical devices, including in-vitro diagnostic medical devices (IVDs) placed on the Great Britain market must be registered with the MHRA. Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A must be registered as of May 1. Other Class IIb, all Class IIa devices, IVD List B products, and Self-Test IVDs must be registered from September 1 on. Class I devices, custom-made devices, and general IVDs (that do not currently need to be registered) must be registered starting January 1, 2022.
Manufacturers of Class I devices, custom-made devices, and general IVDs that were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with Northern Ireland-based Authorized Representatives) prior to 1 January 2021 must continue to register their devices from 1 January 2021 on the same basis as they do now, rather than in line with the above dates.
4. Placing Products on the UK Market
Manufacturers based outside the UK wishing to place a device on the Great Britain market must appoint a single UK Responsible Person who will take responsibility for the product in Great Britain. The designated responsible entity must be registered with the MHRA.
Manufacturers are also required to register with any UK AB to place product on the market. Once they have the necessary certification, their products can be sold anywhere in Great Britain. Following an appropriate assessment, the approved body will issue the relevant certification allowing manufacturers to affix UKCA marking on their products and place them on the market in Great Britain.
Understanding the requirements for each market and the products they apply to is important for any manufacturer moving forward. It will also be important to stay informed of regulation and directive changes, including amendments, revisions, and new standards. While the UK adopted EU regulations as of the start of the year, over time it is expected the UK and EU will adapt their requirements and the two sets of standards will not necessarily be harmonized. Understand what markets you wish to enter, assessment requirements, marking needs, and NB ability. Working with a trusted third party who understands the industry, the requirements, and how to gain market access will be critical.
Bruce McGill is vice president of global certification at Intertek, a multinational assurance, inspection, product testing, and certification company headquartered in London, England.
1. UK Legislation & Directives
By withdrawing from the EU, the UK government removed itself from EU Directives and Regulations that are important considerations for medical device development, testing, certification, and production. Applicable legislation for medical devices in the UK is based on EU legislation in place as of the first of January 2021. However, changes made to EU legislation after that point will not necessarily translate to the UK.
Under the UK Medical Devices Regulations of 2002, the following medical device legislation is in effect for Great Britain:
- 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)
Manufacturers will need to demonstrate that medical device meets these requirements by carrying out product conformity assessments. This will vary based upon the device’s classification, per the applicable legislation. That is to say a general medical device, which must adhere to Directive 93/42/EEC, will be assessed/evaluated differently than an active implantable medical device or in-vitro diagnostic device, which must be tested to their specific standards.
It may also be possible to use an international standard designated to the UK MDR 2002. Examples include (but are not limited to) ISO 13485, which applies to quality management systems for medical device manufacturers, and ISO 14971, covering medical device risk management. Other process-specific standards may also be covered by the UK MDR 2002, like those related to sterilization. Products that comply with the designated standards will conform with the relevant parts of the UK directive covered by these standards.
There are also standards specific to individual types of medical devices or to certain considerations for medical electrical devices and equipment, such as electromagnetic compatibility (EMC). Compliance to applicable standards is illustrated through marking and labelling, which is granted by a UK approved body (AB). For medical devices, ABs are organizations designated by the MHRA to assess whether manufacturers and their medical devices meet requirements set out in the Medical Device Regulations 2002. Marking and labelling requirements for the UK have been modified with Brexit.
2. Marking & Labelling
Currently, CE marking is recognized in Great Britain, and will continue to be until June 30, 2023, for products already on the market. Likewise, certificates issued by EU-recognized notified bodies (NBs) will continue to be valid for the Great Britain market until the same date. However, the EU no longer recognizes UK ABs, meaning these organizations are unable to issue CE certificates unless they are jointly an EU NB and UK AB, which some labs have opted to do—particularly for the Northern Ireland market. And, as of July 1, 2023 CE marking will no longer be accepted in England, Scotland, or Wales. Instead, a new route to market and product marking is available for manufacturers wishing to place a device on the market in Great Britain: the UK Conformity Assessed (UKCA) mark.
The UKCA mark is the new product mark for certain goods place on the market in England, Wales, and Scotland. It applies to most goods that previously required CE marking, including medical devices. UKCA marking went into effect in January 2021. In some circumstances, UKCA marking is required immediately for certain items, such as newly designed products yet to be placed on the market. Those same products will require CE marking for the EU. Until 2023, goods must affix the UKCA on a label, to the product, or an accompanying product. After the first of January in that year, UKCA marking must be affixed directly to the products.
UKCA marking can only be placed on a product (or label) by the manufacturer or an authorized representative, where specified by legislation. The manufacturer takes full responsibility for the product’s conformity with requirements of the relevant legislation. UKCA marking illustrates compliance with UK legislation only. Markings that may misconstrue the meaning or form of the UKCA marking cannot be used. The mark’s proportions cannot be changed, and it must be at least 5 mm in height. It must be easily visible, legible, and as of 2023, permanent. Where relevant, the number of the Notified Body or Approved Body must also appear on the label.
Manufacturers with a valid CE marking on their device aren’t required to relabel the device with a UKCA mark until 1 July 2023. Devices can have both marks present on the labelling prior to 1 July 2023, and dual marking 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 where the UKCA mark has been affixed (including when devices have been dual marked).
Just as the EU does not recognize UK ABs, they will also not recognize the UKCA mark. Products intended for both the UK and EU markets can be marked with both CE and UKCA markings, provided they are fully compliant with applicable regulations, and so long as neither impedes the visibility of the other. Manufacturers should work with their certification partner to have products evaluated and marked for both certification schemes.
In Northern Ireland, the CE mark will be accepted on products, provided they come from an EU conformity assessment body. If manufacturers choose to use a UK AB for conformity assessments for products requiring an assessment, they must apply a UKNI mark in addition to the CE mark for this region. The UKNI mark must accompany the CE conformity mark; it can never appear on a product alone and should only appear on products with specific legislation requiring it. It must be applied to the product itself or the packaging, with the possibility to feature it in manuals or supporting documents in some cases. The UKNI mark applies to and is valid in Northern Ireland only. To place goods on the EU market, manufacturers must use the CE marking on its own without the UKNI mark. Devices bearing both the CE and UKNI marks will not be accepted on the EU market.
3. Device Registration
As of January 1, all medical devices, including in-vitro diagnostic medical devices (IVDs) placed on the Great Britain market must be registered with the MHRA. Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A must be registered as of May 1. Other Class IIb, all Class IIa devices, IVD List B products, and Self-Test IVDs must be registered from September 1 on. Class I devices, custom-made devices, and general IVDs (that do not currently need to be registered) must be registered starting January 1, 2022.
Manufacturers of Class I devices, custom-made devices, and general IVDs that were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with Northern Ireland-based Authorized Representatives) prior to 1 January 2021 must continue to register their devices from 1 January 2021 on the same basis as they do now, rather than in line with the above dates.
4. Placing Products on the UK Market
Manufacturers based outside the UK wishing to place a device on the Great Britain market must appoint a single UK Responsible Person who will take responsibility for the product in Great Britain. The designated responsible entity must be registered with the MHRA.
Manufacturers are also required to register with any UK AB to place product on the market. Once they have the necessary certification, their products can be sold anywhere in Great Britain. Following an appropriate assessment, the approved body will issue the relevant certification allowing manufacturers to affix UKCA marking on their products and place them on the market in Great Britain.
Understanding the requirements for each market and the products they apply to is important for any manufacturer moving forward. It will also be important to stay informed of regulation and directive changes, including amendments, revisions, and new standards. While the UK adopted EU regulations as of the start of the year, over time it is expected the UK and EU will adapt their requirements and the two sets of standards will not necessarily be harmonized. Understand what markets you wish to enter, assessment requirements, marking needs, and NB ability. Working with a trusted third party who understands the industry, the requirements, and how to gain market access will be critical.
Bruce McGill is vice president of global certification at Intertek, a multinational assurance, inspection, product testing, and certification company headquartered in London, England.
