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EU HTA Regulation: Taskforce To Develop Evaluation Framework For Digital Medtech

 
• By Eliza Slawther

Several national health technology assessment bodies in Europe have joined forces with EU-level organizations to develop recommendations on harmonized evaluation guidelines for digital medical devices under the upcoming EU Regulation on HTA.

Medical Software
• Source: Shutterstock

A taskforce co-chaired by France’s Ministerial Delegation for Digital Health and the European Network for Health Technology Assessment (EUnetHTA) has been launched with the aim of establishing “real-world-ready” recommendations on how best to evaluate the cost and clinical-effectiveness of digital medical devices (DMDs).

In a statement published on 26 October, the French National Authority for Health (HAS) outlined how key representatives from...

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New Guidelines Support Early Intervention With Edwards TAVR Device Sapien

 
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The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.

Have Your Say On EU Digital Regulation Overkill

 
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European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

Breast Tissue Regeneration: Tensive’s Journey To Restore ‘Wholeness’ For Cancer Survivors

 
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Medtech Insight spoke with Sanjay Kakkar, Tensive CEO, about the firm’s breast tissue regeneration implant and its surgical benefits, including a reduced operation time of 74 minutes. He anticipates regulatory approval for Regenera in early 2027.

Asabys Partners Talks SafeHeal €10M Investment At LSI Europe

 
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SafeHeal has secured an additional €10m for its Colovac device, bringing its total funding to €97.5m. Led by Asabys Partners, this funding offers both economic and clinical benefits, potentially reducing costs and complications associated with temporary stomas.

More from Geography

Malaysia’s MDA At Asia Forum: ‘Regulatory Silos Are Not The Way Forward Anymore’

 
• By Ashley Yeo

MDA, the Malaysian medical devices regulator, told the 2025 APACMed conference about its efforts on regulatory convergence, harmonization and reliance, which are top of its priority list for aiding medtech regulatory workflows and granting faster access to innovative devices.

FDA Oversight Still Falling Short on Women’s Safety, Advocate Finds

 
• By Elizabeth Orr

Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.