Services We Offer in Europe Union

The European Community has formally adopted several Directives (or regulations – see below) governing the registration of medical devices in Europe. This means that any company interested in selling a product in one of the European Community countries must comply with the applicable Regulation’s requirements and must mark its product with the CE symbol in accordance with those requirements. The Medical Device Regulation 2017/745, which went into effect on May 25, 2017, became mandatory on May 26, 2021, and replaced the Medical Device Directive and the Active Implantable Medical Device Directive (those are no longer an option to obtain CE marking). The In Vitro Diagnostic Regulation 2017/746 entered into force on May 25, 2017, and it will become mandatory on May 25, 2018.


EU CE Marking

European Authorized Representative

Free Sale Certificate (EU)

EUDAMED Registration

Clinical Evaluation Report

Post Market Surveillance

Technical Files Writing