Specculo acts as your EU Authorised Representative (EC REP) and supports the EU Importer role, the legal presence non-EU manufacturers need to place medical devices and IVDs on the European market under MDR and IVDR. 

As your Authorised Representative we verify that your technical documentation and Declaration of Conformity are in order, register your details and devices in EUDAMED, keep records available for competent authorities, cooperate on vigilance and post-market surveillance, and act as the point of contact for regulators across the EU. We also advise importers and distributors on their own obligations so your supply chain stays compliant. Unlike high-volume AR providers, we combine the mandated representation with genuine regulatory expertise, so issues are spotted and resolved rather than simply logged. 

The service includes a compliance check before we take on the mandate, a clear written agreement defining responsibilities, EUDAMED registration support, and ongoing handling of regulatory correspondence and vigilance duties. We can also deliver tailored training and knowledge transfer for your internal team, covering MDR/IVDR essentials, EUDAMED and post-market obligations, so you build in-house capability over time. 

The service suits non-EU manufacturers entering or already selling in the EU who need a reliable, expert representative rather than a passive mailbox. The outcome is continuous, audit-ready EU representation backed by senior regulatory support.