Medical Devices Excluded From EU Cyber Resilience Act Proposals

Medtech companies will avoid the need to comply with yet another EU regulation, it seems, after the European Commission confirmed that proposals to tighten up cybersecurity rules for internet-connected products will not apply to medical devices.

DARK HACKER
• Source: Shutterstock

Proposals for the European Commission’s Cyber Resilience Act (CRA) were firmed up on 15 September. The legislation sets out plans to introduce EU-wide common cybersecurity rules for manufacturers and developers of products with digital elements - covering a vast range of devices, from children’s toys to household appliances.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems

 

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.

Opportunity For Medtech To Contribute To EU Cybersecurity Recommendations

 

The deadline for comments is 30 June 2025

EU Harmonized Standards Continue To Trickle In Under MDR

 

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
• By 

The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.

More from Geography

EU Harmonized Standards Continue To Trickle In Under MDR

 

Well over 200 European standards need harmonizing under the MDR. But only around 12% have been attended to so far.

Medtech Looks For Relief As Trump Hits Pause On Most Tariffs

 
• By 

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.

Medtechs Eye German Health Minister Switch As Governing Parties Reach Coalition Agreement

 
• By 

The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.