New Medical Device and In Vitro Diagnostic Regulation in the EU - Webinar CD/Transcript

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New Medical Device and In Vitro Diagnostic Regulation in the EU: What You Need to Know to Make the Right EU& US Market Entry Decisions

Following the “scandals” related to metal-on-metal artificial hips and faulty silicone breast implants, the European Commission put forward a draft legislative proposal in 2012 to revise the medical device and in vitro diagnostic regulations to improve patient safety while encouraging medical device innovation.

The Commission intends to do this by:

  • Extending the scope and reclassification of devices and in vitro diagnostics
  • Pre-market scrutiny for high risk devices
  • Reinforced rules for clinical evidence
  • Tightening post-market surveillance
  • Increasing traceability via UDI system to enhance post-market safety requiring manufacturers hire a person responsible for regulatory compliance
  • Strengthening supervision of notified bodies by authorities

While preparing for a more robust regulatory regime in the EU, you must also keep an eye on the FDA in the wake of the U.S. presidential election. The new administration is signaling the need for quick action across all industries and the president campaigned on the importance of clearing up the FDA’s backlog of product approvals.

Join Michael M. Gaba — Life Science Partner, Holland & Knight LLP, USA — and Shayesteh Fürst-Ladani founder and CEO, SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland for a discussion on the biggest anticipated changes to the EU and U.S. medical device framework and their impact on global go to market strategies, including the extent to which a company can harmonize its regulatory effort for the global market.

After this 90-minute session you’ll know:

  • How to handle the EU’s expanded pre-market expectations for medical device manufacturers
  • How to prepare for amplified post-market surveillance in the EU
  • What to expect when working with notified bodies under this new regulatory regime
  • The extent to which a company’s regulatory processes in the EU and US can be harmonized
  • What to expect from the FDA’s new legal authorities to influence medical device approvals
  • What factors to consider, including the impact of Brexit, when making your decision about first point of market entry:  EU or US?

Order today and learn what you need to know to make the right EU and U.S. market entry decisions.

  • Regulatory affairs professionals
  • Product lifecycle managers
  • Approval and submissions specialists
  • Government relations professionals

Meet Your Presenters

Michael M. Gaba, Life Science Partner, Holland & Knight LLP, USA
Michael M. Gaba is a partner in the Washington, D.C., office of Holland & Knight where he is the federal policy leader of the firm’s national Healthcare & Life Sciences Team. His regulatory and legislative life sciences practice includes counseling and representing medical device and biotech companies before the U.S. Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the U.S. Congress. Mr. Gaba advises clients on the complex intersection of FDA regulatory issues and CMS coverage and payment issues, including federal health policy matters created by these sister agencies. He also provides pre-market strategic counseling and post-market surveillance and enforcement advice, with a particular focus on combination product approval, labeling and promotion.

Shayesteh Fürst-Ladani, founder and CEO, SFL Regulatory Affairs & Scientific Communication Ltd., Switzerland
Shayesteh Fürst-Ladani leads the team at SFL and provides global strategic support for the development of healthcare products. Shayesteh has longstanding experience in formulating global regulatory strategy for drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics (IVDs) and advanced therapy medicinal products (ATMPs). Shayesteh has been involved in reviewing and assessing the impact of European and US legislation, such as the cell & tissue directive, the advanced therapy medicinal products regulation, the orphan medicinal product regulation, and reviewing requirements impacting drug & device combination products, personalized medicine and HTA.