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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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• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 
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June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
• By Amanda Maxwell

The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

More from Geography

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 
• By Brian Bossetta

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

June 2025: A Bumper Month For New EU Medtech Documents And Initiatives

 
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The rate at which new documents to support the implementation of EU medtech regulations are issued has slowed of late; but June bucked the trend, with a flurry of activity.

NICE’s Rules-Based Pathway And Innovator Passports Get Go-Ahead In UK NHS 10-Year Plan

 
• By Ashley Yeo

The NHS 10-Year Plan officially released on July 3 will crystalize NICE’s Rules-Based Pathway – a new concept for medtech evaluation that will come with a guarantee of funding – but only for a select number of products. Government to also introduce “innovator passport” to speed innovation into NHS.