In January 2021, the UKCA mark has officially become a part of UK law and will be mandatory in the next two years.
FREMONT, CA: Now the medical device companies with products on the UK market will have to obtain the UK Conformity Assessment (UKCA mark), so far these devices were sold with the CE mark, which was a requirement under EU law since 1985. This UKCA mark will be mandatory from 1 July 2023, which gives medtech manufacturers two years to adhere to this. Although, as witnessed from earlier times, such delays to the EU's Medical Regulation have no impact with regards to compliance, it doesn't necessarily mean every business will be ready when the time arrives. The devices will be allowed to be sold in the UK market using a CE mark till June 2023, but after 1 July, all medical devices and in-vitro diagnostics (IVDs) must necessarily have the UKCA mark to be sold.
After the 2023 deadline, the manufacturers will need to take care of several steps to ensure their goods can be sold. Jon Higham, Medicine Direct managing director, states that the threshold to obtain the UKC certification mark will be similar to that of the requirements for the CE mark. Furthermore, he added that labeling requirements for the medical devices will be the same as that of the CE mark and that it will require listing on the label of the UK Responsible Person (UKRP) for the medical devices. For the companies to get hold of the UKCA mark, they must get registration from the UK medicines and Healthcare products Regulatory Agency (MHRA) for their devices or IVD. Several UK Approved Bodies are put in order which will function similar to that of EU NBs which conducts assessments against the relevant requirements and grant the UKCA mark.