Why do you need an Authorized Representative?
Under the Regulation (EU) 2017/745 () and Regulation (EU) 2017/746 (IVDR), the company must contract an Authorized Representative in Europe. This requirement demands that any foreign company must have a regulatory representative in Europe whose purpose is to serve as a liaison between the foreign company and the national Competent Authorities (Ministries of Health).
Additionally, the Authorized Representative will:
- Assist with certain device registrations, as required.
- Be identified on the product labeling throughout Europe.
- Maintain a current copy of the Technical Documentation and CE Declaration of Conformity available for inspection by a Competent Authority.
- Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with the company and/or its distributors.
Helpful tips when selecting an Authorized Representative:
- When selecting an Authorized Representative, prioritize one with deep and current knowledge of EU requirements and direct experience responding to Competent Authority inquiries — so they can efficiently provide requested documentation, communicate with regulators in official languages, and support your company if compliance questions or challenges arise.
How we can help?
A. Stein – Regulatory Affairs Consulting maintains strong relationships with multiple Authorized Representatives and understands their specific strengths, allowing us to guide you in identifying the Authorized Representative most appropriate for your medical device and regulatory needs.
