Unsure about rules for using the UKCA marking

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A UKCA (conformity assessment) mark is a logo that is placed on medical devices to show they conform to the requirements in the UK MDR 2002. It shows that the device is fit for its intended purpose stated and meets legislation relating to safety. It shows the product can be freely marketed in Great Britain (England, Wales and Scotland). Image files are available here.

You must make sure that:

  • if you reduce or enlarge the size of your marking, the letters forming the UKCA marking must be in proportion.
  • the UKCA marking is at least 5mm in height – unless a different minimum dimension is specified in the relevant legislation.
  • the UKCA marking is easily visible, legible.

 

The UKCA marking can take different forms (for example, the colour does not have to be solid), as long as it remains visible, legible and maintains the required proportions.

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

  • a custom-made device – but it must still meet the requirements in the UK MDR 2002
  • undergoing a clinical investigation – it must include ‘exclusively for clinical investigation’ 
  • an in vitro diagnostic medical device for performance evaluation
  • a non-compliant device used in exceptional circumstances (humanitarian grounds)

 

(reference: MHRA and gov.uk)

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