UKCA mark update    

Following the UK’s exit from the European Union (EU), the requirements for medical devices have been laid out in legislation in the form of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). The UK MDR covers the rules for devices placed on the market in the UK (Great Britain (GB) and Northern Ireland (NI)), and incorporates the requirements as set forth in the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), the Medical Devices Directive 93/42/EEC (MDD) and the In vitro Diagnostic Devices Directive 98/79/EC (IVDD). 

Since 1 January 2021, there have been two currently recognised routes of access to the UK market: continued use of the CE mark, or voluntary use of the UKCA mark. After an extended transition period, on 1 July 2023 the UKCA mark will become mandatory for medical devices placed on the market in Great Britain. 

This presentation provides an overview of UKCA medical device marking requirements for manufacturers wishing to access the UK market now and past the end of the transition period after 30 June 2023.  


Date and time: Monday, 8 November 2021, 12.30 pm (CET)

Your speaker: Dr Monisha Phillips | Head of MHS Certification Body (UK) 

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