About Us
EU Authorised Rep Services
EU Authorised Rep Services
EU Authorised Rep Services
An EU Authorised Representative (EU AR) acts as a liaison between non-EU medical device manufacturers and EU regulatory authorities. They ensure compliance with EU regulations, including MDR (2017/745), maintain technical documentation, and handle communications with notified bodies and competent authorities. EU AR services are essential
An EU Authorised Representative (EU AR) acts as a liaison between non-EU medical device manufacturers and EU regulatory authorities. They ensure compliance with EU regulations, including MDR (2017/745), maintain technical documentation, and handle communications with notified bodies and competent authorities. EU AR services are essential for manufacturers seeking to sell medical devices in the European market.
We help non-EU medical device manufacturers enter and thrive in the European market—without the headaches. With us as your Authorised Representative, you're always audit-ready and compliant.
What we do
EU Authorised Rep Services
EU Authorised Rep Services
With extensive experience in the prehospital medical market, we also provide business consulting services focused on market entry and expansion.
Our background in R&D, operations, and sales across the UK, Europe, and the US has enabled us to build a network that we can leverage to your advantage.
Structure
EU Authorised Rep Services
Structure
Our lean structure means every client gets direct access to senior regulatory expertise, fast response times, and hands-on support through every MDR requirement. We're not just your EU AR—we're your dedicated partner in market access and compliance. .