Authrorized Representative (AR)

Your EU Presence

We act as your legal representative in the European Union. Medical device manufacturers located outside the European Economic Area (EEA) are required under EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to appoint an EU Authorized Representative when placing devices on the European market. The EEA includes all EU Member States as well as Iceland, Liechtenstein, and Norway.

We ensure your products meet MDR and IVDR requirements for market access.

What We Do

• Regulatory representation

• Technical documentation oversight

• Communication with authorities

• Post‑market vigilance coordination

Go to PRRC Services

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