EU Cyber Resilience Act Should Include Medtech, Says Data Protection Watchdog

The European Commission’s decision to exclude medical devices from the scope of its proposed Cyber Resilience Act was praised by industry, but this could all change, as the EU’s data protection supervisor argues that medtech should be included in the legislation.

Cybersecurity Concept
• Source: Alamy

Medical devices that fall within the regulatory scope of the EU’s Medical Device Regulation (MDR) were confirmed to be among the few categories of product excluded from the commission’s draft Cyber Resilience Act in September This was under the logic that sector-specific rules are sufficient to keep products safe from cyberattacks.

This decision was met with a sense of relief from the medtech industry, as manufacturers are already grappling with both the new MDR requirements and, where applicable, horizontal laws around

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

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By 

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

23andMe Purchase Will Let Regeneron Scale Drug Development

 

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

More from Geography

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By 

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

23andMe Purchase Will Let Regeneron Scale Drug Development

 

The consumer genomics firm will operate as a subsidiary, while Regeneron plans to leverage its database for drug discovery and trial design efforts.

Disparities — Including Financials Shortcomings — Remain In Women’s Health, Execs Say

 

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.