Performing authorised representative duties in the UK for medical device companies.

In compliance with FDA 21 CFR 807.40, we provide regulatory agent services (US Agent) for medical device companies.

An EU-authorised representative is a natural or legal person expressly designated by a manufacturer located outside the EEA (including the EU and EFTA) as an EU-Representative, i.e. an EU-authorised representative, also known as an EU-representative. This natural or legal person can perform on behalf of a manufacturer outside the EEA the specific duties required of the manufacturer by the relevant EU directives and laws.