UKCA Marking is mandatory for all medical devices sold in the United Kingdom from January 1st, 2023. Most items formerly subject to the CE certification are now subject to the UKCA Mark. Contact us to know in detail about medical device regulations in the UK.
UK Conformity Assessment process has not yet been published officially. However, the UKCA self certification process will likely be similar to new MDR and IVDR regulations covering Clinical evaluation Reports and Performance evaluation reports. All manufacturers planning to sell medical devices in the UK market has to develop an in-house team or identify an external consulting team early for the Conformity Assessment process.
UK Marking Medical Devices Regulation 2002 (SI 2002 No 618, UK MDR 2002) is active from January 1st’ 2021. MHRA is under the process of releasing new regulation in line with European Medical Devices Regulation. The new regulation is expected to release early 2023.