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The UK governments overhaul of medical device regulation came into force on the 16th June 2025. It requires device manufacturers to actively track the safety and performance of products already in use. This will help identify potential safety issues earlier and strengthen protection for patients and the public through faster responses to incidents and emerging risks.
What do you notice about the new regulation? There’s no emphasis on cybersecurity, there’s not a word, a smidgin, a teaser, a single reference. It’s mentioned in an ancillary document, and plans to include cybersecurity requirements at a later date. That risks exposing UK citizens personal data to actors that want access to it; as demonstrated earlier this year when US Federal Agencies found back doors in medical devices. That shared data with China.
https://lnkd.in/e-dseas8
Our US partners take a different view. The 2023 the US FDA introduced medical device cybersecurity regulation.
https://lnkd.in/exuBMvAc
@Thaddeus Dziekanowski Brian D. McCarthy Faisal Khan
Veritas GRC
#cybersecurity #cyberriskmanagement #cyberregulation
https://lnkd.in/eD44mRUp
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