New UKCA Mark As It Pertains To Medical Devices

The UK Conformity Assessed Mark (UKCA) is the new United Kingdom (UK) product mark that will be used for certain goods being placed on the market in Great Britain (GB – England, Wales and Scotland), following the UK’s exit from the European Union (EU). The UKCA Mark will replace the CE mark completely (see further down for enforcement dates) and covers most goods that previously required CE marking.

SUMMARY OF KEY REQUIREMENTS FOR PLACING A MEDICAL DEVICE ON THE BRITISH MARKET:

Since January 1, 2021, there have been changes introduced by secondary legislation for medical devices placed on the market in Great Britain.
These are:

• CE marking will continue to be recognized in Great Britain until June 30, 2023 for certain devices
• Certificates issued by EU-recognized Notified Bodies will continue to be valid for the Great Britain market until June 30, 2023.
• The EU no longer recognizes UK Notified Bodies
• UK Notified Bodies are not able to issue CE certificates (other than for the purposes of the “CE UKNI” marking, which is valid in Northern Ireland) – and have become UK Approved Bodies.
• A new route to market and product marking is available for manufacturers wishing to place a device on the Great Britain market
• Since January 1, 2021, all medical devices – including in vitro diagnostic medical devices (IVDs) – placed on the Great Britain market need to be registered with the MHRA. The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom (similar to the FDA in the United States) which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The grace period for registering is as follows:
  • Class IIIs and Class IIb implantables, and all active implantable medical devices and IVD List A products, must be registered from May 1, 2021
  • Other Class IIb and all Class IIa devices and IVD List B products and Self-Test IVDs must be registered from September 1, 2021
  • Class I devices, custom-made devices and general IVDs (that do not currently need to be registered) must be registered from January 1, 2022.
• Manufacturers of Class I devices, custom-made devices and general IVDs that, prior to January 1, 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with Northern Ireland-based Authorized Representatives) must continue to register their devices from January 1, 2021 on the same basis as they do now, rather than in line with the above dates
• If you are a manufacturer based outside the UK and wish to place a device on the Great Britain market, you need to appoint a single UK Authorized Representative who will take responsibility for the product in Great Britain. Further detail on the UK Authorized Representative is set out below.

LEGISLATION THAT APPLIES IN 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)

These directives are given effect in UK law through the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). These Regulations (in the form in which they existed on January 1, 2021) continue to have effect in Great Britain after the transition period. This means that since January 1, 2021, the Great Britain route to market and UKCA marking requirements are still based on the requirements derived from current EU legislation.

RECOGNITION OF EXISTING CE CERTIFICATES FOR THE MARKET OF GREAT BRITAIN:

Under the UK MDR 2002 (as amended), a CE marked device with a valid declaration of conformity or certificate is viewed as meeting the UKCA mark requirements while the CE marking will be recognized in Great Britain until June 30, 2023. This includes devices placed on the market that are: CE marked in conformance with the EU MDD, EU IVDD or EU AIMDD CE marked in conformance with the EU MDR or EU IVDR. Therefore, any enforcement or market surveillance powers available in respect of the UKCA mark also apply to CE marked devices placed on the Great Britain market. Where certificates have been issued by a UK Notified Body, the 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 mark.

LABELLING REQUIREMENTS:

Medical devices placed on the Great Britain market must have a UKCA mark or a CE mark, depending on which legislation the device has been certified under. Where relevant, the number of the Notified Body or Approved Body must also appear on the label. If you already have a valid CE marking on your device, you are not required to re-label the device with a UKCA mark until July 1, 2023 for placement on the Great Britain market. Devices can have both marks present on the labelling prior to July 1, 2023, and dual marking will continue to be accepted on the Great Britain market after July 1, 2023. However, the name and address of the UK Authorized Representative, where applicable, needs to be included on product labelling where the UKCA mark has been affixed (including when devices have been dual marked).

UKNI MARKING:

UK Notified Bodies can conduct conformity assessments for the purposes of the Northern Ireland market. In addition to the CE marking, device manufacturers also need to apply the UKNI marking if they choose to use a UK Notified Body for mandatory third-party conformity assessment. Device manufacturers must never apply the UKNI marking on its own – it must always accompany a CE marking. To place goods on the EU market, manufacturers must use the CE marking on its own, without the UKNI marking. Goods bearing the “CE & UKNI” marking will not be accepted on the EU market.

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

• you are placing certain medical devices on the Northern Ireland market; and
• your goods require mandatory third-party conformity assessment; and
• you use a UK Notified Body to carry out those conformity assessments.

The UKNI marking is sometimes referred to as the UK(NI) mark or the UK(NI) indication, including in Article 7(3) of the Northern Ireland Protocol. These terms refer to the same marking.

Most medical devices required EU Notified Body reviews.

• When placing goods on the UK market, in most cases the client will still be able to use the CE mark from January 1, 2021. The CE marking will only be accepted in the UK up until January 1, 2022. Note: The UKCA marking alone cannot be used for goods placed on the Northern Ireland market, which requires the CE mark or CE and UK (NI) mark.

The client can CE mark if any of the following apply:

• Client currently CE marks their existing goods on the basis of self-certification and mandatory third-party conformity assessment was carried out by an EU-27 recognized Notified Body.
• The certificate of conformity previously held by a UK body has been transferred to an EU-27 recognized Notified Body.
• In certain cases, the client will need to apply the new UKCA marking to goods being sold onto the GB market from January 1, 2021 for new products which have not been placed onto the market (new products – new design) with no existing CE certified approval.

Note: The EU does not recognize the UKCA mark (like the EU not recognizing an NRTL mark).

ASSESSMENT ROUTES:

The client will need to demonstrate that their medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment. The assessment route depends on the classification of the device.

1. General medical devices
2. Active implantable medical devices (AIMD)
3. In vitro diagnostic medical devices (IVD’s)

COMPLIANCE WITH DESIGNATED STANDARDS:

The client has the option to use any international standard that has been designated to the UK MDR 2002. If the client complies with these designated standards, they will conform with the relevant parts of the directive that are covered by these standards. This includes standards such as ISO 13485 covering quality management systems for medical device manufacturers and ISO 14971 covering risk management for medical devices and other process-specific standards, such as those covering sterilization.
There are also standards which are specific to individual types of medical devices. The use of standards is not mandatory; however, most manufacturers choose to use them.

EXEMPTIONS:

The client should not place a UKCA mark on your medical device if it is:

• A custom-made device – although it must still meet the requirements in the UK MDR 2002 and the type of device should be labelled clearly
• Undergoing a clinical investigation – it must include ‘exclusively for clinical investigation’ and meet the requirements as far as possible – you must take precautions to protect the health and safety of patients • an in vitro diagnostic medical device (IVD) for performance evaluation
• A non-compliant device used in exceptional circumstances (humanitarian grounds)

The client does not need get these checked by a third party to show they conform with the requirements, but they need to draw up a statement to declare their compliance for custom-made devices, clinical investigations and performance evaluation devices.

APPROVED BODY:

A client is required to register with an Approved Body to place product in the UK. An Approved Body is an organization that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Device Regulations 2002 (https://www.legislation.gov.uk/uksi/2002/618/contents/made).

Manufacturers can apply to any UK Approved Body, and once they have the necessary certification their products can be sold anywhere in Great Britain (England, Wales and Scotland). Following an appropriate assessment, the Approved Body will issue relevant certification allowing manufacturers to place UKCA marking on their products and place them on the market in Great Britain.

Although the UKCA mark will be available for use in Great Britain from January 1, 2021, CE marking will continue to be needed for devices placed on the Northern Ireland market and EU rules will need to be met. CE marked devices will also be accepted on the Great Britain market until June 30, 2023. From January 1, 2021, to place a CE mark on a medical device for circulation in both Northern Ireland and the EU, manufacturers must use an EU-recognized Notified Body to undertake any mandatory third-party conformity assessment. The results of conformity assessments carried out by UK notified bodies will not be recognized within the EU. Duly designated UK Notified Bodies will be able to conduct conformity assessments for the purposes of the Northern Ireland market alone. For these products, in addition to the CE marking, device manufacturers will also need to apply the UKNI marking. These products cannot circulate on the EU market.

If you have questions about any of the information above, or would like your products reviewed to determine what steps need to be taken to ensure your devices are properly marked in accordance with the regulations as laid out herein, please contact Testing Partners at (862) 243-2677 or email Testing Partners at customerservice@testingpartners.com.