UKCA stands for United Kingdom Conformity Assessed and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation – is recognized in the UK until the 30th of June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.

manufacturers now need to plan for how they will obtain a UK Conformity Assessment mark before 30th June 2023. As many have seen, there have been delays in obtaining the mark, so the quicker manufacturers act, the better.

Operon strategist is medical devices consulting has a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process, UKCA marking, and licensing you can connect with us.