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.
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Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.
AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.
The deadline for comments is 30 June 2025
Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.
Biotech and pharma are increasingly clear about one thing: They need diagnostics. But with prices suppressed, how have diagnostics companies proven their utility without going under?
Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.
The medtech industry hopes to use a 90-day pause on tariffs to negotiate a “zero for zero” exemption. However, recent public comments from President Donald Trump suggest the health care sector may still be at risk.
