Definition: As an EU Representative (EU Rep), we act as the authorized representative for non-EU manufacturers, serving as their point of contact with EU authorities and ensuring compliance with regulatory obligations. This applies to all products in our scope, including Medical Devices, IVDs, cosmetics, and chemical mixtures.
Scope and Relevance:
For Medical Devices and IVDs, Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) require non-EU manufacturers to appoint an EU Rep to handle regulatory submissions, market surveillance, and incident reporting.
For Cosmetics, Regulation (EC) No 1223/2009 mandates an EU-based Responsible Person (often the EU Rep) to manage CPNP notifications and Product Information Files.
For Chemical Mixtures and Aromas and Fragrances, we facilitate REACH compliance (Regulation (EC) No 1907/2006) by acting as a liaison for ECHA submissions. Our Role: We manage regulatory communications, maintain documentation, and ensure compliance with EU obligations, enabling non-EU manufacturers to access the EU market seamlessly.
