UK Conformity Assessment process not yet published officially, it is likely that UKCA Mark certification process will be similar to that of new MDR and IVDR regulations covering Clinical evaluation Report 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.
Most items formerly subject to the CE certification are now subject to the UKCA Marking. UKCA Mark Certification is mandatory for all medical devices sold in the United Kingdom from January 1st 2023 onwards. Contact us to know in detail about UK medical device regulation.
UK Medical Device Regulation 2002 (SI 2002 No 618, is know as UK MDR 2002) is active from 1st January’ 2021