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UKCA Marking - extension of standstill period

The MHRA explained its intention to extend the standstill period of using the CE Mark by 12 months to 30 June 2024 for the medical devices. The extra year is designed to allow the MHRA , UK the time needed to fully develop the legislation and ensure support system readiness. This is of great importance for the Medical Devices industry, since the CE Marking of the EU can continue to be used without restrictions for one more year.


Find the official document attached below.


MHRA - extension of standstill period
.pdf
Download PDF • 118KB


Rules for using the UKCA image

In the case that you have a Medical device class I or you already obtained your UKCA mark the MHRA had established the recommendations to follow.

As per the MHRA for placing the UKCA 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 to the version set out below

  • 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 and indelible

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.


Find the UKCA MHRA for medical devices in the file below.


ukca-mark-fill (1)
.zip
Download ZIP • 838KB

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