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What is UK Conformity Assessed (UKCA)

Manufacturers must register their device or IVD with the UK Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA has designated several UK Approved Bodies, which function similarly to EU NBs and can conduct assessments against the relevant requirements to grant UKCA marking.

Existing UK NBs have been automatically rolled over into this new categorisation, without having to undergo a new designation process.

Medical devices are divided into four classes in the UK, in accordance with the UK Medical Device Regulations 2002,generally based on the intended purpose of the device, how long it’s intended to be used and how invasive it is:

  • Class I: low-risk devices like wheelchairs or stethoscopes
  • Class IIa: medium-risk devices such as surgical clamps
  • Class IIb: slightly more complex medium-risk devices like bone fixation plates
  • Class III: high-risk devices such as pacemakers

IVDs are also classed into four risk categories:

  • ‘General’ IVDs, which are not covered by the following three categories
  • IVDs for self-testing: like the lateral flow tests used to screen for Covid-19
  • List B IVDs: reagents products for rubella, toxoplasmosis and phenylketonuria (among others), as well as devices for self-testing for blood sugar
  • List A IVDs: reagents and products for HIV I and II, hepatitis B, C and D, as well as reagent products for determining blood groups and anti-Kell, including those used to test donated blood, plus tests for screening Variant Creutzfeldt–Jakob disease

 

Manufacturers of Class I devices and low-risk general IVDs like specimen receptables can generally self-declare their UKCA conformity. Class I devices will still need to receive official approval if they are sterile or have a measuring function.

Not all medical devices can leave it until 2023 to register. In January, the MHRA set the following deadlines for registration for certain classes of device:

  • 1 May 2021: active implantable medical devices, Class IIb implantable devices, Class III medical devices and IVD List A devices
  • 1 September 2021: Class IIb non-implantable medical devices, Class IIa medical devices, IVD List B devices and self-test IVD products
  • 1 January 2022: Class I medical devices and general IVDs from manufacturers based outside of the UK

 

Further details can be found on https://www.gov.uk/guidance/using-the-ukca-marking