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Centralized Medtech Regulation: Which Way Should The EU Go?

 
• By Amanda Maxwell

Centralized regulation will be beneficial for classification and borderline decisions, orphan device decisions, and recertifying notified bodies. But it is not a panacea for EU medtech in the view of Sabina Hoekstra-van den Bosch.

Silver Bullet
Centralization is not a 'silver bullet' to end EU medtech's problems • Source: Shutterstock

There had been quite some dismay among medtech stakeholders that the recent European Parliament resolution to the European Commission proposing critical changes to the EU’s Medical Device Regulation omits a proposal for centralized governance, a measure that many now believe is critical to the future success of the EU’s medtech regulation.

But this topic topped the medtech issues agenda at the final EPSCO (Employment, Social Policy, Health and Consumer Affairs Council)...

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