UKCA Mark Labelling requirements for Medical Devices

UKCA Mark Labelling Requirements

 

UKCA mark or a CE Mark logo is a must depending on which legislation the device has been certified under. The Certificate issuing Notified Body or Approved Body number must also appear on the label.

If the device is already CE Marked you are not required to re-label the device with a UKCA mark until 1 July 2023 . Duel marking (UKCA & CE Marking) is accepted on the Great Britain market after 1 July 2023. but the name and address of the UK Responsible Person (UKRP), needs to be included on product labelling where the UKCA mark has been affixed.