Key Responsibilities of the EU Authorized Representative
The responsibilities of the Authorized Representative are described not only in the MDR and IVDR but also in an MDCG guidance document “MDCG 2022-16- Guidance on Authorized Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU)2017/746 on in vitro diagnostic medical devices (IVDR).” The mutual obligations between the manufacturer and the EC REP are recorded in a written mandate.
Regulatory Compliance
Perhaps the most critical role of the Authorized Representative is to ensure that the medical devices comply with the regulatory requirements set forth by the MDR or IVDR. This involves thorough knowledge and interpretation of the complex regulatory framework and staying updated with any amendments or revisions and related standards and guidance.
Product Registration
The EU Authorized Representative is involved in the registration process. We assist non-EU manufacturers in preparing and submitting the necessary technical documentation to the relevant EU authorities or the Notified Bodies. This also includes reviewing and approving labeling materials, instructions for use, and any other documentation required for compliance.
Post-Market Surveillance
Monitoring the performance and safety of medical devices in the EU market is another key responsibility of the EU AR. They act as the point of contact for collecting and reporting adverse events, complaints, or incidents related to the devices, ensuring timely communication with the relevant authorities.
Representation in the EU
Serving as the official representative of the non-EU manufacturer, the EU AR must be established within the European territory. This physical presence is essential for effective communication with regulatory authorities and facilitates inspections or audits as required.
Conclusion
In conclusion, the role of the EU Authorized Representative or EC REP is indispensable for non-EU manufacturers seeking to market their medical devices in the European Union. From regulatory compliance to post-market surveillance, the Authorized Representative plays a multifaceted role in ensuring the safety, efficacy, and quality of medical devices available to EU consumers. By understanding and embracing the responsibilities of the EU AR, manufacturers can forge a pathway to compliance and market success in the dynamic landscape of EU medical device regulation.
What we can do for you
With many years of experience in the development and registration of medical devices we do not only review the technical documentation but also provide best practices in creating the technical documentation. In contrast to a notified body, we do not carry out a review and then give feedback, but rather accompany the creation of the technical documentation and provide continuous feedback.
We can assist in the identification and implementation of applicable safety and security standards.
Furthermore, we provide support throughout the registration process of the medical device in the European database on medical devices (EUDAMED) and perform the registration in the Austrian Medizinprodukteregister (medical device register).
By Verena Wieser, Medical Device Consultant
