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EU’s New Cybersecurity Guidelines: Not Perfect, But Key Signposting For All Involved

 
• By Amanda Maxwell

How do the EU’s new cybersecurity guidelines expand on the MDR and fit into the myriad other software-related guidance documents the medtech industry has to consider?

Cyber security

When it comes to medical device cybersecurity guidance in the EU, the good news is that a new guidance document is available and provides some important signposting to manufacturers and other medtech economic operators, as well as to IT operators and users on how to interpret the Medical Device Regulation (MDR).

But the more regrettable news, in the view of Simmons & Simmons lawyers Annabelle Bruyndonckx and Vladimir Murovec, is that...

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MHRA’s Tallon Lays Out His Philosophy On Healthcare Products Regulation

 
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As Medtech Tariffs Loom, AdvaMed Responds With Its Own Plan Emphasizing ‘Reciprocal’ Free Trade

 
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Fixing The Fractures: New Aspirations For EU Medtech Regulatory Progress

 
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More from Geography

Medicare’s TCET Pathway Wins Acclaim From Early Users, Even As ‘Messy Middle’ Persists

 
• By Brian Bossetta

Some of the first manufacturers to receive Medicare coverage for their breakthrough devices through the Transitional Coverage for Emerging Technologies pathway praise CMS’ engagement and timelines in the process, despite some challenges around post-launch data collection.

German Medtechs Choking Under EU Compliance And Reporting Obligations Tout Mutual Recognition

 
• By Ashley Yeo

Industry survey points to ongoing low revenues rise and weaker profit levels for half of BVMed industry association members in 2025, as German manufacturers raise stakes on global harmonization.

Fixing The Fractures: New Aspirations For EU Medtech Regulatory Progress

 
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