Fabien Roy

As partner of our Life Sciences practice, Fabien Roy focuses his practice on advising clients on EU and national regulatory matters applicable to medical devices, in vitro diagnostic medical devices, medicinal products and other regulated products (e.g. CE marked products, food, feed, cosmetics, AI tools). Fabien closely follows the new regulations on medical devices (MDR and IVDR) and GDPR and regularly advises clients on the requirements applicable to their digital health technologies. With a practice entirely focusing on complex regulatory issues faced by Life Sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling clients to focus on their business.

Fabien guides clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices and assists clients in addressing complex issues during clinical investigation procedures (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data), conformity assessment and registration procedures (e.g. prepare and review of technical documentation, prepare and review of responses to the competent authorities' and Notified Bodies' requests) and post-market activities (e.g. adverse event reporting, Field Safety Corrective Actions and promotional and advertising of medical devices).

Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device clients. Fabien also assists clients in preparing, drafting and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European Authorised Representative Agreements and distribution agreements.