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UK responsible person for Medical Devices /UK Medical Devices Authorized Representative
For medical devices and in vitro diagnostic medical devices, after the United Kingdom (UK) leaves the European Union (EU), any UK-based Medical Devices Authorized Representative will no longer be recognized under EU law. This means they will not be recognized as able to carry out tasks on the manufacturer’s behalf for the purposes of placing products on the EU market. In order to place devices on the EU market, manufacturers with a Medical Devices Authorized Representative based in the UK will need to establish a new Medical Devices Authorized Representative in an EU country. This role is also called: UK Responsible Person.
This new role has been created under the UK MDR 2002 (as amended by the UK MDR 2019), which applies from the day the UK leaves the EU. The UK Responsible Person or UKRP, who must be established in the United Kingdom (UK), acts on behalf of a manufacturer established outside the UK to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the United Kingdom market.