UKCA marking for medical devices

The UK medical devices, are regulated by the Medicine and Healthcare product Regulatory Agency (MHRA). If a medical device manufacturer wants to place their product in Great Britain then they need to have UKCA marking meaning UK product marking. UKCA stands for UK Conformity Assessed, UKCA marking is a substitute for the EU requirement of CE marking. The guidance provides information that includes; getting device–certified, conformity marking, and registering the device with MHRA.One thing to note here is that as per the Northern Ireland protocol, rules to place a device in Northern Ireland market differ from Great Britain. UKCA is product marking needed for the placement of medical devices in the UK market. The term medical device here also includes in vitro diagnostic medical devices and active implantable medical devices. For the Northern Ireland market CE mark or UKNI mark is required for the placement of medical devices in the Northern Ireland market.

Exemptions: One should not put a UKCA mark on the product if,

The product is exclusively for clinical investigation and meets the requirement as far as possible.
an in vitro diagnostic medical device (IVD) for performance evaluation
a non-compliant device used in exceptional circumstances (humanitarian grounds)
Custom made device that meets the requirement in UKMDR 2002

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