ECLIPSE MEDTECH LIMITED

Eclipse Medtech Ltd is a specialist regulatory consultancy that serves medical‑device manufacturers located outside the European Union. Acting as a European Authorised Representative, the company holds a written mandate to fulfil the obligations set out in the EU Medical Device and In‑Vitro Diagnostic Regulations, including maintaining technical documentation, liaising with the Health Products Regulatory Authority and other competent bodies, and managing complaints and incident reporting on the manufacturer’s behalf.

The team’s expertise extends to reviewing technical files efficiently, communicating with the HPRA and a range of other authorities, and providing a UK Responsible Person service through its parent, Insight Regulatory Consultancy Ltd. This dual capability enables clients to access both EU and UK markets through a single point of contact. Eclipse Medtech offers its Authorised Representative service at a transparent, fixed price, calculated on the number of device types covered, with no hidden fees for file reviews or regulatory interactions.

Based in Ireland, Eclipse Medtech benefits from the country’s status as an English‑speaking gateway to Europe and the strong support of the HPRA, making it an ideal partner for non‑EU manufacturers seeking compliant market entry.