Medical device UKCA marking practicalities
01 December 2021
UKCA (UK Conformity Assessed) marking is the UK product marking requirement that is now required for any product placed on the market in Great Britain (GB), substituting the European Union’s (EU) requirements for CE Marking. This includes all medical devices.
For medical devices, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provides guidance on how medical devices are now being regulated. As of 1 January 2021, medical devices being placed on the market in the UK must follow new legislation: the Medical Devices Regulations 2002 (SI 2002 No 618, as amended), known as UK MDR. The UK MDR incorporates the requirements, according to EU legislation, for:
• Active implantable medical devices – Directive 90/385/EEC (AIMDD)
• General medical devices – Directive 93/42/EEC (MDD)
• In vitro diagnostic medical devices – Directive 98/79/EC (IVDD)
Timescales
Although the UKCA mark may be required to place medical devices on the market in GB, from 1 January 2021, CE marked devices are also permitted. However, from 1 July 2023, it will be mandatory for every medical device to display the UKCA marking.
Read the full article in DPA's December issue
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