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BSI’s Gary Slack Explains Why MDR Take-Up Is So Slow

 
• By Amanda Maxwell

There is not much demand currently for testing against the EU's Medical Devices Regulation (MDR). But demand for certificate renewal under the current medical device directives is very high. What does all this mean as the EU attempts to introduce tighter requirements for medical devices?

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Despite being designated under the MDR in January this year, BSI, one of Europe’s largest medtech notified bodies, has only issued one certificate under the MDR so far. It does not expect to issue more than ten by the year end.

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More from Europe

Anglonordic 25: Pictura Bio’s One-Minute Pathogen-Identifying Diagnostic Test

 
• By Natasha Barrow

“Infectious disease should be treated in the community, not in hospitals,” Alex Batchelor, Pictura Bio CEO, told Medtech Insight at the Anglonordic Life Science Conference on 3 April in London.

Medtech Strategy Must Be Priority, German Diagnostics Firms Tell Government

 
• By Ashley Yeo

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.

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

 
• By Natasha Barrow

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

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

More from Geography

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

 
• By Natasha Barrow

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

 
• By Amanda Maxwell

The deadline for comments is 30 June 2025

Diagnostics Are Essential, But How Can Companies Ensure A Fair Price?

 
• By Barnaby Pickering

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?