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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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