European Authorized Representative
European Authorized Representative services and consulting
Due to the importance of the role of the authorized representative, the MDR and the IVDR have defined the responsibilities of the manufacturer and the authorized representative in detail in Articles 10, 11 and 12.
These must be regulated, among other things, in a mandate agreement between the EC-REP and the manufacturer.
Acting as an authorised representative for a manufacturer based outside the EU requires sound legal, regulatory and technical due diligence, which is in the best interests of the manufacturer and the authorised representative.
In addition, a close network and partnership with the leading liability insurers is a must in order to provide a reliable service that adds value beyond the ‘name on the label’.
Medicamentum GmbH has the necessary expertise and partnerships and ensures the service of an authorised representative for manufacturers of medical devices outside the EU.
Medicamentum GmbH assists in setting up and executing the EC-REP mandate: • Development and implementation of the mandate agreement that defines rules and interfaces in accordance with the EU regulations
• Verify and ensure compliance of devices with the essential requirements set out in the applicable European Directive (i.e. 93/42EEC, 90/385EEC, 98/79EC) or Regulations 2017/745 MDR and 2017/746
• Support in the clarification of insurance requirements, provision of appropriate expert contacts to leading liability insurance companies in the life science sector
• Provide EC-REP contact details for labelling, packaging and instructions for use
• Support in implementing the necessary adaptations of your packaging, labelling and IFU to national requirements of the member states
• Registering your medical devices with the competent national authorities before placing them on the market
• Keeping your technical documentation available for inspection by the competent European authorities, ensuring the confidentiality of your documentation.
• Carrying out audits of your partners within the EU (suppliers, distributors, etc.)• Ensuring the necessary communication in the event of vigilance, coordinating activities in the context of incidents (field safety notices, recalls, field safety corrective action) with the authorities, the importer and distributors
• Informing about the current status of the applicable EU regulations for each of the 27 EU member states and the 4 EFTA states, informing about changes and additions to directives and regulations that would affect individual products
• Notifying the relevant authorities in the event of serious incidents
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