Representative Services

European Authorized Representative Service

Non EU manufacturers of medical devices which do not have a subsidiary or a local point of contact within the EU are legally required to appoint a so called European Authorized Representative who will act as a central point of contact for Competent Authorities. The EAR furthermore will maintain a current copy of your Technical File which will be available for inspection by the European Competent Authorities and assists with the notification of reportable serious incidents.

Legal Representative Service

The Clinical Trial Directive 2001/20/EC requires non European Sponsors of drug clinical trials to appoint a so called Legal Representative who needs to be established within the European Economic Area. CLINSTEP can offer this service through our networking partner. In addition CLINSTEP offers a full range of clinical trial services designed to facilitate the approval and the conduct of such clinical trials.

• Legal Representative for non EU sponsors of clinical trials
• Qualified Person
• Assisting with CTA applications and submitting CTAs to the EudraCT database
• Assisting with EC applications and submitting them on behalf of the sponsor
• Clinical Trial Project Management
• and more.