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EU MDR and IVDR Cybersecurity Measures Not Enough To Prevent Attacks, Warns ENISA

 
• By Eliza Slawther

An expert from the European Union Agency for Cybersecurity (ENISA) has told Medtech Insight that although the new EU Medical Device and IVD Regulations will push developers to make more secure products, regulation is not enough to prevent cyberattacks on devices and digital health systems.

CYBER KEYBOARD
• Source: Shutterstock

The European Commission has sought to tighten requirements for medical device companies in the new MDR (2017/745) and IVD Regulation (IVDR, 2017/746); all medical devices that incorporate electronic programmable systems and software that in themselves are medical devices are subject to the new rules.

Evangelos Ouzounis, head of ENISA’s policy development and implementation unit, told Medtech Insight that while the EU MDR and IVDR...

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More from Europe

Home-Testing Added To UK National Cervical Cancer Screening Program

 
• By Natasha Barrow

NHS England will offer at-home cervical cancer self-testing kits to people who are overdue for routine screening by six months. The Department of Health and Social Care identified four HPV collection and testing combinations with highest accuracy.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

More from Geography

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 
• By Brian Bossetta

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By Ashley Yeo

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.