Feature

Medical device UKCA marking practicalities

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.

01/12/2021 12:18:08

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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

Written By Sophia Bell

Sophia Bell is the Group Editor of DPA, Connectivity, and PBSI. She joined the team in 2020 as Assistant Editor after achieving a First-Class Honours BA in English Literature and Film Studies from the University of East Anglia. In her current role, she leads the editorial strategy, driving digital growth and ensuring each title continues to deliver trusted, relevant insight for engineering and manufacturing professionals.