Live Webinar | US & EU: Where to Start with Your Novel Devices

Date: 23 September, 2026

Time: 16:00 - 17:00 CET | 10:00 - 11:00 am EDT

Location: Virtual

Introduction

Growing uncertainty around MDR 2.0 is prompting more MedTech manufacturers to rethink the assumption that Europe is the natural place to launch a novel device. The US offers greater regulatory clarity, but at a higher cost, and with review timelines now stretched by FDA staffing cuts.

So, where should your novel device go to market first? In this session, our experts weigh the pros, cons, and practical realities of each path so you can make the call with confidence.

The session features a 45-minute informal presentation followed by a live Q&A. You can submit your questions through the registration form, by email at marketing@qservegroup.com, or directly during the event.

Learning Objectives: 

By attending this webinar, participants will be able to:

• Compare the EU and US regulatory pathways for novel devices across cost, timeline, and predictability.
• Assess how ongoing MDR 2.0 uncertainty should factor into your market-entry strategy.
• Evaluate the real-world impact of FDA staffing cuts and longer review timelines on a US-first approach.
• Identify the key questions that determine which market should come first for your specific device.
• Build a defensible rationale for sequencing your global market entry.
  

Who should attend? 

This webinar is designed for MedTech professionals involved with novel medical devices, including:

• Regulatory Affairs professionals shaping market-entry strategy
• Manufacturers that are indecisive on which pathway to pursue first
• Teams with commercial interests across the EU, US, and/or China markets

This is particularly valuable if you are bringing a novel device to market and weighing where to start.