The UKCA (UK Conformity Assessed) marking came into effect on 1 January 2021. It is a new product marking used for goods being placed on the British markets (England, Wales and Scotland).
Manufacturers of medical devices and providers of medical software solutions who have CE marking, have been able and are able to continue selling their products in the Great Britain until the end of June 2023. From 1 July 2023 the UKCA is required for the medical device on the British market. Note that most other goods must have the UKCA marking in place already from 1 January 2023 onwards at the latest.
If your medical device is already on the British market, you should have started preparing for the UKCA marking already by now. As a new company not selling your product yet in the Great Britain, this is something you should start preparing straight away when you are seriously aiming at the British market.
Business Finland UK
janna.mure (at) businessfinland.fi