Fabien Roy | Brussels | Hogan Lovells

Fabien Roy

Partner Global Regulatory


English, French

Roy Fabien

Fabien Roy
Roy Fabien
  • Overview
  • Experience
  • Credentials
  • Insights and events
quote mark

'Fabien Roy is very responsive with any requests and has a strong business-oriented mindset, with significant understanding of our products.'

Chambers Europe/Belgium Life Sciences: EU, 2023

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.

quote mark

'He listens to clients' needs and provides very reasonable and pragmatic approaches to situations.'

Chambers Europe/Belgium Life Sciences: EU, 2023

Representative experience

Advised a CRO on understanding the requirements that apply to its companion diagnostics assays and overall interaction between the IVDR and the Clinical Trials Regulation

Acted as Data Protection Officer in the EU for a gene therapy company to set up a GDPR compliant framework for upcoming clinical trials in the EU and UK and on future clinical activities in the EU/UK

Advise a leading biopharma company on an ongoing basis with supply chain, manufacturing and clinical trials regulatory aspects throughout Europe concerning its authorised and investigational ATMPs

Advised Several clients on questions related to the regulatory classification of AI-powered medical device software

Advised a medical devices client on a global product recall for one of their products following customers complaints

Advised a medical devices manufacturer resolving legal challenges by a national competent authority on labelling practices for legacy products under the EU Medical Devices Directive via commitments


  • D.E.S.S. European Law, Université de Rennes 1, with merit, 2007
Bar admissions and qualifications
  • Brussels
  • The European Forum for Good Clinical Practice (EFGCP)-MedTech Europe Working Party
  • Qualified Lead Auditor ISO 13485 and MDSAP


Band 3 in Life Sciences: EU

Chambers Europe/Belgium

Next Generation Partner in EU Regulatory: Pharma, Medical Devices, and Biotech

Legal 500 EMEA

Ranked in EU Regulatory: Pharma, Medical Devices, and Biotech

Legal 500 EMEA

Rising Star, Life Sciences, Belgium

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