What is CE Marking?
CE Marking shows that a medical device demonstrates compliance with EU medical device regulations and meets essential standards. It requires devices to obtain a conformity assessment certificate from a Notified Body and demonstrate compliance with the EU MDD/MDR or IVD/IVDR.  The UK currently accepts both the UKCA and CE Marking. The Medicines and Healthcare products Regulatory Agency (MHRA) will also continue to recognise European CE Marking in Great Britain until between 2028 and 2030, depending on the type of CE Marking.