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What Regulators Want To See From AI And Software-Based Devices

 
• By Eliza Slawther

Experts in software and AI medtech regulation from the UK’s MHRA have outlined the questions that device developers should seek to answer when preparing for the regulatory process.

Assessment
• Source: Shutterstock

Defining the intended purpose of a medical device should be the starting point for manufacturers entering the regulatory process, yet software-based devices often have a poorly-defined intended purpose, Paul Campbell, head of software and artificial intelligence at the UK regulator, the MHRA, told a conference on 6 July.

Campbell, who has just this month been appointed to lead on software and AI at the Medicines and Healthcare products Regulatory Agency (MHRA), said that manufacturers are “encouraged to really...

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EU Finalizes Framework For Joint Clinical Assessments Of High-Risk Devices

 
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UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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More from Geography

UK Take Care! Regulatory And Market Access Reforms Must Not Shut Out Medtech Growth

 
• By Ashley Yeo

Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.

Roche Diagnostics Day 2025: ‘We Need To Become A Leader In Decentralized Testing’

 
• By Natasha Barrow

Roche aims to grow its diagnostics sales by mid to high single digits, said CEO of Roche Diagnostics Matt Sause. The company unveiled the Axelios synthesis and sequencing solution and discussed its “long-term commitment” to China, as well as its business strategy for the next five years.

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel