Fiscal vs. Authorized Representative: Which Do You Need in France?

For non-EU medical device manufacturers targeting the French market, a common point of confusion is the distinction between a Fiscal Representative for tax obligations, like the upcoming 2026 VAT changes, and the mandatory EU Authorized Representative (AR) required under the Medical Device Regulation (EU) 2017/745. While both are essential for market access, their functions are distinct. How can a manufacturer develop a robust evaluation framework to select a qualified AR that goes beyond mere registration and name-on-the-label services? Specifically, for a company producing a connected, Class IIa Software as a Medical Device (SaMD), what practical criteria should be used to assess an AR’s competency? For example, how should a manufacturer verify that a potential AR has the technical expertise to understand and support post-market surveillance (PMS) and vigilance reporting related to software anomalies or cybersecurity events, aligning with principles seen in guidance like FDA’s *Cybersecurity in Medical Devices*? What specific questions should be asked to determine if the AR has established processes for managing communication with Notified Bodies and Competent Authorities during a field safety corrective action (FSCA) involving a software patch? Furthermore, what contractual provisions are critical to ensure the AR can adequately review and provide input on the manufacturer’s technical documentation and PMS plans to confirm ongoing compliance with the MDR throughout the device lifecycle? --- *This Q&A was AI-assisted and reviewed for accuracy by Lo H. Khamis.*