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First Expert Panel Opinion Offers Valuable Learning Opportunities

 
• By Amanda Maxwell

BSI would have been disappointed if it had received the comments featured in the first expert panel opinion, but vice-president Gary Slack believes the report provides many insights and opportunities around how this scrutiny process will impact the sector.

Training and development business education concept with a hand holding a group of gears transferring the wheels to a human head made of cogs as a symbol of acquiring the tools for career learning. - Illustration

Expert opinions should raise the bar in the EU for the clinical review of high-risk devices by notified bodies, in what Gary Slack, senior vice president of the notified body at BSI Regulatory Services (Medical Devices), calls a much-needed improvement.

This is because the level of clinical scrutiny of these products by notified bodies has been “variable” in the past,...

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More from Europe

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
• By Ashley Yeo

The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 
• By Natasha Barrow

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.

More from Geography

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By Elizabeth Orr

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.

Medtronic’s ‘Strategic Expansion’ Into Remote Monitoring

 
• By Natasha Barrow

“The Corsano wearable strengthens Medtronic’s acute care and monitoring portfolio,” Marc De Martini, vice president at Medtronic, told Medtech Insight.

European Commission Asks For ‘Open Minds’ On Unified Drug/Device Research Pathway

 
• By Vibha Sharma

As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.