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Europe's MedTech Races Ahead Despite Global Headwinds
29 May
Summary
- New EMA pilot program supports patient access to innovative medical technologies.
- Regulatory pathway aims to speed up certification for novel devices.
- Class III and implantable devices are eligible for the pilot program.
Innovation is surging in Europe's medical device and in vitro diagnostics sector, overcoming geopolitical hurdles like the war in Ukraine and supply chain disruptions. Industry leaders gathered at the MedTech Forum in Stockholm to discuss these advancements.
A key development is the European Medicines Agency's (EMA) innovative device pathway pilot program, initiated on April 26. This voluntary pilot aims to accelerate patient access to cutting-edge medical technologies.
Oliver Bisazza, CEO of MedTech Europe, lauded the pilot as essential for maintaining innovation within the region. Flora Giorgio from the European Commission highlighted that the program prioritizes novel devices meeting unmet needs, encouraging Notified Bodies to expedite their certification.
This European approach differs from other global regulators, offering an open-ended pilot to inform future legislation. Class III and implantable devices are currently eligible, with applications closing on May 22. Companies are advised to engage early with Notified Bodies to understand how the pilot aligns with the EU's Medical Device Regulation.
