Mastering the UKCA Compliance Challenge

January 1, 2021, ushered in significant change for the UK but also for medical device manufacturers worldwide wishing to continue to sell their products in this market. Although it is merely the start of a transition period toward a new regulatory regime, businesses would do well to take note of a series of deadlines and dates, culminating with the June 30, 2023, the date by which their devices must have obtained UKCA marking to continue to be present in this market. In addition to working toward achieving compliance for the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device businesses with products on the UK market will need to plan ahead to ensure that they achieve UK compliance in time.