UK Responsible Person

According to the UK Medical Devices Regulation 2002 (SI 2002 No.618, as amended), all medical device and in vitro diagnostic (IVD) manufacturers located outside the UK that want to place a medical device (or IVD) on the Great Britain market (England, Wales and Scotland) are required to appoint a UK responsible person (UKRP).

Evnia Authorized Representative

Evnia UKRP Services

Ensure that the declaration of conformity and technical documentation have been drawn up

Maintain a copy of technical documentation, available to authorities
Provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
Comply with any request from the MHRA to provide such samples or access to the device
Cooperate with the MHRA to eliminate or mitigate the risks posed by devices
Support post-market surveillance activities (e.g., complaints, incidents, recalls)

UKCA certification

Starting from 1 July 2024, a UK Conformity Assessment (UKCA) certification will be required by all manufacturers that want to place their medical devices or in vitro diagnostics in the Great Britain (GB; England, Wales and Scotland) market (UK MDR SI 2002 No. 618, Part II, Section 10). 

Online device registration

All medical devices, including IVDs intended to be sold in the GB market should be registered in Medicines and Healthcare products Regulatory Agency (MHRA).


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