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Why Vital EU Guidance For Clinical Investigation Plans Is So Challenging To Read

 
• By Amanda Maxwell

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

The EU’s Medical Device Coordination Group has published guidance on the content of the clinical investigation plan for clinical investigations of medical devices, MDCG 2024-3.

This 21-page document is relevant to any sponsor creating a clinical investigation plan (CIP) in the context of the EU’s...

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More from Europe

Siemens Healthineers Mitigates Headwinds With ‘Value-Add Structural Changes’

 
• By Natasha Barrow

Siemens Healthineers anticipates €400m-€500m tariff impact by 2026 but says it will mitigate losses through structural changes and pricing. Despite a revenue decline in diagnostics due to China’s VBP, diagnostics transformation activities, including cutting product, were “successful."

Roberts’ Departure At NICE Sparks Hunt For New CEO

 
• By Ashley Yeo

Healthtechs are reflecting on the resignation of Sam Roberts as chief executive of NICE and how medtech assessment program changes underway at the England and Wales HTA body might be impacted.

CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

How Notified Bodies Would Like Future EU Medtech Governance To Pan Out

 
• By Amanda Maxwell

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.

More from Geography

CorTec Begins First Human Trial Of Wireless Brain Implant For Stroke Rehab

 
• By Marion Webb

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

Bipartisan Senate Bill Would Give Patients ‘True Price Tag’ Prior To Care

 
• By Brian Bossetta

Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.

How Notified Bodies Would Like Future EU Medtech Governance To Pan Out

 
• By Amanda Maxwell

Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.