Fabien Roy is a recognized legal and regulatory leader and technical advisor for medical devices and in vitro diagnostic companies, with a strong reputation for developing effective regulatory strategies at EU and international level and for successfully resolving complex issues with competent authorities and third parties, including EU notified bodies.
With nearly two decades of experience advising life sciences companies, Fabien supports clients across a broad range of regulatory frameworks covering medical devices and IVDs, medicinal products (including ATMPs), combination products, and other regulated products such as food, feed, and cosmetics. He is particularly valued for his ability to translate complex regulatory requirements into pragmatic, business-oriented solutions and to lead complex, cross-border regulatory projects.
Fabien has a strong capability to lead pan-European and international regulatory projects and regularly advises on complex due diligence transactions involving companies operating across multiple jurisdictions. His work in this area includes assessing regulatory compliance, identifying risk exposure, and developing remediation strategies in the context of acquisitions, investments, and strategic partnerships.
Fabien is a trusted adviser on AI and digital health solutions, closely monitoring regulatory developments and guidance related to the AI Act, data protection and privacy legislation, and their interaction with medical devices and pharmaceutical regulatory frameworks. Known for anticipating regulatory hurdles, he helps clients remain compliant while advancing innovative technologies and commercial objectives.
He regularly assists clients with the preparation of product qualification and classification, CE marking strategies, technical documentation, quality management systems, products recalls, compliance programs (e.g.: promotion and advertising, interaction with HCPs, sunshine requirements), responses to inspection and audit findings in the EU and internationally.
In addition to his role as a regulatory lawyer, Fabien is also an ISO 13485 and MDSAP lead auditor. As such, he has in-depth knowledge of quality management systems and the full spectrum of quality and compliance issues faced by medical device manufacturers. He also advises on the preparation, drafting, and review of a broad range of agreements, including those related to clinical studies, registries, distribution, sponsors’ representatives, CROs, and European Authorized Representative arrangements.
Experience
- Multiple clients in preparing for the MDR and IVDR and addressing non-conformities raised by their notified bodies.*
- A medical devices client with the preparation of a worldwide recall strategy including the preparation of Field Safety Corrective Actions (FSCA)/Field Safety Notices (FSN).*
- Multiple medical devices companies on the transition from the EU MDD to the EU MDR, including on conformity assessments, the optimization of the supply chain structure, optimal use of existing instruments and ongoing update on new developments and potential impact.*
- A CRO regarding the requirements that apply to its companion diagnostics assays and overall interaction between the IVDR and the Clinical Trials Regulation.*
- A gene therapy company as Data Protection Officer in the EU to establish a GDPR-compliant framework for upcoming clinical trials in the EU and UK.*
- A leading biopharma company in providing ongoing advice regarding supply chain, manufacturing, and clinical trials regulatory aspects throughout Europe concerning its authorized and investigational ATMPs.*
- Several clients on questions related to the regulatory classification and regulation of AI-powered medical device software.*
*Represents experience with previous employer.
Perspectives
Recognition
EU Regulatory: Pharma, Medical Devices, and Biotech
Credentials
Education
- D.E.S.S., European Law, Rennes 1 University, 2007, with merit
- Master of Public Law, University of Silesia (Katowice, Poland), 2006
Admissions
- Brussels, Belgium
Certificates
- Qualified Lead Auditor, ISO 13485 and MDSAP (2019)
- Internal Auditor, 13485-2016 (2019)
Activities
- European Forum for Good Clinical Practice-MedTech Europe Working Party
Languages
- English
- French