UK Responsible Person (UKRP)

The UKRP is a legal entity appointed to ensure compliance with regulatory requirements for medical devices in the UK market.

Having a UKRP is mandatory for all manufacturers base outside the UK wanting to sell in the UK, to fulfill post-Brexit legal obligations and ensure your medical device meets the UK standards.

The UKRP is responsible for device registration, overseeing device compliance, maintaining technical documentation and communicating with regulatory authorities on behalf of MedTech manufacturers.

We provide expert guidance, perform regulatory tasks, and act as the liaison between you and UK authorities, ensuring a smooth market entry for your medical devices.

Since 26 May 2021, the EU MDR has applied in Northern Ireland and the EU IVDR has applied in Northern Ireland since 26 May 2022.

Therefore, when placing devices on the Northern Ireland market, Great Britain-based and non-EU manufacturers must appoint an EU or Northern Ireland-based Authorised Representative. We can do this for you, acting as your designated EUREP to support market access.

You’ll become an ‘importer’ if you’re the one bringing goods for the first time into Northern Ireland from either Great Britain or another non-EU country and placing them on the Northern Ireland market. Only businesses established in Northern Ireland or a European Economic Area (EEA) state can act as ‘importers’ for the Northern Irish market.