Medtech

The European Union mandates that any international manufacturer intending to distribute its devices within Member States must appoint an exclusive authorized representative (European Authorized Representative, or EU REP) with a physical presence in one of these Member States.

This European Authorized Representative will act as the intermediary between the company and the national authorities.
As such, it must ensure immediate access to the company’s most recent technical files, a prompt response (within 24 hours) for incident and Field Safety Corrective Action (FSCA) reporting, as well as serve as the primary point of contact for the competent authority.

The EU REP is also responsible for registering the devices in EUDAMED before they are commercialized. The representative’s name and registered address must appear on all product-related labeling.

RPN offers comprehensive solutions to meet the requirements related to the EU REP, including:

• Identification and designation of the EU REP.
• Comprehensive review of the EU declaration of conformity and technical documentation.
• Preparation and registration of the initial product in EUDAMED.
• Timely updates and maintenance of product registration in EUDAMED.
• Support in facilitating communication between the Competent Authority and the manufacturer.
• Coordination and assistance in handling complaints and reporting incidents to the Competent Authorities.
• Regular updates on regulatory changes that could impact devices and registrations.
• Expert advice on effective registration strategies.