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What Does The EU Regulation On HTA Mean For Medtech And When Will It Apply?

 
• By Eliza Slawther

Several updates have come in recent weeks on the European Commission’s planned new Regulation on HTA, including a list of stakeholder members and updated rolling timeline. Medtech Insight explains how and when this legislation will affect the medtech sector.

Medical Software
• Source: Shutterstock

Health technology assessment (HTA) processes for drugs and medical devices are currently the sole responsibility of individual member states, but the new EU HTA Regulation will set a legal framework for joint, EU-level assessment processes and common methodologies.

What Is HTA?

Health technology assessment is a means of evaluating a medical product for its clinical and cost-effectiveness, taking into consideration clinical evidence, a comparison...

While the Regulation on HTA will not affect all medtech products, and will not apply until at least 2025 or later, manufacturers should familiarize themselves now with the new legislation....

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