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Medical Device Development and Market Strategy: Europe or US First? Or Both?

Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive, and more predictable than getting US FDA clearance or approval. With the introduction of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the paradigm has shifted, and an increasing number of medical device companies are prioritizing the US market. However, the decision of where to launch first must be guided by more than just regulatory requirements.

In an evolving global regulatory landscape where technology is advancing rapidly, medical device developers need to adopt a holistic approach to aligning their product development and go-to-market strategies to optimize the likelihood of regulatory and commercial success. In this webinar, we will explore key considerations for prioritizing markets and optimizing the path to product launch.

Topics will include:

  • Comparison of the regulatory landscapes for medical devices and IVDs in the EU and US
  • Risk classification of medical devices and IVDs in the EU and US and its impact on product development and associated requirements
  • How to develop a rigorous clinical and regulatory plan to support your priority market
  • Guidance on aligning your product development and go-to-market strategies
  • Real world examples that bring these key considerations to life

Matthew Nowland, Vice President, Regulatory Affairs, MedTech
Michael Edwards, Senior Director, Regulatory Affairs, MedTech

Download the Webinar