There are still several missing key elements needed for the implementation of the EU’s IVD Regulation. Three key experts focused on how to move forward, particularly with the highest risk, class D, IVDs.
When it comes to compliance with the IVD Regulation, as updated by the recent amending regulation, the biggest challenges relate to the highest risk, class D, IVDs.
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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.
