Global growth in life sciences demands a clear understanding of regulatory landscapes on both sides of the Atlantic. This webinar will bring together insights on navigating evolving UK/EU medtech and healthtech requirements and demystifying the complexities of US regulatory exclusivities—helping companies streamline compliance, unlock protections, and maximize market opportunities.
Navigating the UK and EU Regulatory Landscape for Medtech & Healthtech Companies
Presented by Martin Becker, Regulatory Lead, HealthTech, CPI
UK and EU regulatory frameworks for medtech are in major flux. UKCA is evolving, the EU MDR and IVDR regimes are mature but still challenging. US companies eyeing European markets face hurdles in design-for-compliance, clinical evidence generation, and product lifecycle management. Martin will demystify current regulations, provide practical tips, and showcase how to leverage UK innovation infrastructure to streamline compliance and accelerate market entry.
Exclusivities for and Regulation of Medical Devices and Diagnostics in the US
Presented by Jonathan B. Roses, Shareholder, Pharmaceutical Practice, Wolf Greenfield
Exclusivities for medical devices and diagnostic methods in the US come primarily in the form of patent protection, but the landscape for these products is nuanced and interfaces with regulation and unsettled law governing what can and cannot be protected under the statutory schemes. Jon will review these schemes, uncover pitfalls for the unwary, and highlight areas of uncertainty and how they may potentially be resolved.
