You need to demonstrate that your medical device meets the requirements in the UK MDR 2002 by carrying out a conformity assessment. in vitro diagnostic medical devices (IVDs): Part IV of the UK MDR 2002.active implantable medical devices: Part III of the UK MDR 2002.general medical devices: Part II of the UK MDR 2002.UKCA mark requirements for medical devices are based on the 3 main types of medical devices and their associated Part in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002): A CE mark or CE UKNI mark will be needed for devices placed on the Northern Ireland market. The UKCA mark will not be recognised on the Northern Ireland market. The UKCA mark is a product marking which can be used for medical devices placed on the Great Britain (England, Wales, Scotland) market. For more information on conformity assessments and marking of your device for purposes of the Northern Ireland market, please see the section on Northern Ireland below. Great Britain is England, Wales and Scotland.įor Northern Ireland, different rules apply to those in Great Britain. This guidance is divided into sections on the different rules that apply in Great Britain and Northern Ireland.
This guidance outlines the conformity assessment process for medical devices, and how you can apply a marking to your device.
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