Fabien Roy#3922

Fabien Roy

As a partner of our Life Sciences practice, Fabien Roy focuses his practice at Hogan Lovells on advising Clients on European Union and national regulatory matters applicable to medical devices, medicinal products and combination products throughout their entire life cycle. 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 focuses particularly on guiding Clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures, conformity assessment and registration procedures and post-market activities.

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 Life Sciences Clients in the preparation, 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.

Contributed to

2

An introduction to the regulation of medical devices—EU Directives regime
An introduction to the regulation of medical devices—EU Directives regime
Practice notes

This Practice Note introduces the regime for regulation of the manufacture and sale of medical devices in the EU under Directive 93/42/EEC on medical devices, Directive 90/385/EEC on active implantable medical devices and Directive 98/79/EC on in vitro diagnostic medical devices. It explains how devices are classified, assessed (by completion of a conformity assessment) and CE marked. This Practice Note also considers the advertising and promotion or medical devices, counterfeit medical devices, 3D printing and mobile health.

Regulatory data protection
Regulatory data protection
Practice notes

This Practice Note explains the concept of regulatory data protection (RDP), also known as ‘data exclusivity’, provides guidance on how RDP works in practice and the impact it has on the entry into the market of generic and biosimilar medicinal products.

Practice Area

Panel

  • Contributing Author

Qualified Year

  • 2007

Membership

  • The European Forum for Good Clinical Practice (EFGCP)-MedTech Europe Working Party
  • Qualified Lead Auditor ISO 13485
  • Qualified Lead Auditor ISO 13485

Education

  • Master Degree European Law, with merit, Universit de Rennes 1, 2007

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