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Avoiding MDR Pitfalls On Cybersecurity: How EU Rules Could Catch Manufacturers Out

Interpretation of cybersecurity requirements can be a moot point

 
• By Eliza Slawther

Is it clear which medtech products must demonstrate conformity with EU regulations on cybersecurity? Experts weigh in on the case of an alleged discrepancy between a notified body and a manufacturer on this matter.

Disagreement
• Source: Shutterstock

Medtech innovators face many changes to EU medical device rules under the new Medical Device Regulation, but the introduction of cybersecurity requirements is perhaps one of the most notable additions, given that no such safety provisions existed under the former medtech directives.

However, the need to demonstrate that a product is cybersecure, in accordance with Annex I of the MDR and guidance outlined in MDCG 2019-16 rev. 1, may be open...

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