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The UKCA Mark stands for United Kingdom Conformity Assessment (UKCA) Mark. This is a new product marking adopted by the UK and is applicable for goods being placed in Great Britain. This is a requirement for most of the goods that are subjected to CE Marking, prior to Brexit. Medical Devices require UKCA marking and are also subject to some special rules.

Where is UKCA Mark Valid?

The UKCA Mark is valid only in Great Britain and it will not be recognized in the EU, EEA or Northern Ireland markets. The devices being placed in Northern Ireland market require CE marking or UK(NI) marking. The other markets which require CE mark to market the device such as, the EU and EEA would still require the same.

What are the Timelines for UKCA Mark?

The UKCA marking can be used from 1st January 2021 and is voluntary till 30th June 2023. Medical devices which conform to and which are CE marked under EU MDD, EU AIMDD, EU IVDD, EU MDR and EU IVDR will be accepted and can be marketed till this date. From 1st July 2023, the new devices placed in the Great Britain market will need to conform with the UKCA marking requirements.

What are the Conformity Requirements for UKCA Mark?

From 1st January 2021, Class I medical device and general IVD manufacturers can carry out self-declaration for their conformity to EU MDD or EU IVDD; affix the UKCA mark and launch the device in Great Britain. Manufacturers of these device classes with existing CE mark and self-certification can place the devices in Great Britain market till 30th June 2023. Sterile and measuring Class I devices and devices falling under other risk classes C shall undergo third party assessment by the UK Approved Bodies and shall have an approval from them to  affix the UKCA mark and to place the device in the Great Britain market.

The devices shall comply with applicable annexes to Directive 90/385/EEC on Active Implantable Medical Devices (EU AIMDD), Directive 93/42/EEC on Medical Devices (EU MDD) and Directive 98/79/EC on In Vitro Diagnostic Medical Devices (EU IVDD), to seek the UKCA marking.

Once the UKCA Marking is successfully obtained by the UK Notified body, the manufacturer and UK Responsible Person (UKRP) shall ensure that the device technical file and UK Declaration of Conformity are up-to-date and should be readily available for submission, whenever requested by the Market Surveillance Authority.

What are the Rules for Placing UKCA Marking on the Device?

Whenever the product the device is affixed with an UKCA Mark, the below listed rules apply:

  • Only the manufacturer or the UKRP is authorized to affix the UKCA markings on device labels
  • The UKCA mark affixed on a device label implies that the device conforms to applicable Regulatory requirements and the manufacturer is responsible for the conformity
  • The UKCA mark shall be affixed to reflect product conformity with the relevant UK legislation
  • Any other markings or signages that misconstrue the meaning or form of the UKCA marking to the third parties should not be included
  • Any other markings affecting the visibility, legibility or meaning of the UKCA marking should not be included on the label

Where to Find UKCA Images?

The high resolution and original UKCA mark images can be downloaded from here. The images are available in various formats such as, gif, png, jpg and eps for ease of use by industry. While affixing the UKCA Mark, it should be noted that -

  • the image is reduced or enlarged in a way that the letters are in proportion to the original version
  • the marking is at least 5mm in height
  • the marking is easily visible and legible

Who can Carry Out UKCA Conformity Assessment ?

Starting from 1st January 2021, the MHRA would designate the UK Approved Bodies to conduct conformity assessment of medical devices for UKCA mark. The current UK based Notified Bodies designated under EU MDD, EU IVDD or EU AIMDD will be automatically approved for UKCA marking assessments. The new bodies have to undergo detailed approval process to be designated for carrying out the UKCA conformity assessments. A new database is being set up by the UK Government to include the list of the UK Approved Bodies, which is expected to play a similar role as the EU’s NANDO (New Approach Notified and Designated Organisations) Information System.

UKCA Mark and Device Labeling

From 1st January 2021, medical device label to be placed in Great Britain should include:

  • The UKCA mark or a CE marking, depending on which legislation the device has been certified under
  • The number of the Notified Body or Approved Body
  • The devices with a valid CE marking do not need the UKCA mark until 1st July 2023
  • Devices can have both the UKCA and CE marks affixed till 1st July 2023 and the dual marking will be accepted after 1st July 2023
  • The devices with UKCA mark (including dual labelled) affixed on their labels shall include the UKRP details

For more information about UKCA marking and CE marking or to align with the industry standards for the best of compliance efforts, reach us at sales@freyrsolutions.com.