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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.

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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 several national HTA bodies will collaborate with academic experts to...

“The goal of this taskforce is to facilitate the accessibility of DMDs across the EU,” the HAS said. The project has been coordinated by EIT Health while the University of...

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Swiss Medtechs Advised To Work On US Tariff Mitigation Strategies

 
• By Ashley Yeo

The US’ 90-day suspension of higher “reciprocal tariffs” will expire on 9 July, raising fears that the 31% tariff rate on Swiss medtech and other goods exported to the US might make a comeback. While the tariff situation changes on an almost daily basis, medtechs should forearm for any eventually, say local business organizations.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

More from Geography

Guardant Health Launches Germline Hereditary Cancer Test

 
• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.