The International Medical Device Regulators Forum (IMDRF) has published its final guidance document N60, Principles and Practices for Medical Device Cybersecurity, setting a globally harmonised approach to cyber security across the medical device lifecycle.
Key points
- Promotes a total product lifecycle approach, from secure design through post-market management.
- Emphasises shared responsibility between manufacturers, healthcare providers, users and regulators.
- Covers risk management, security testing and coordinated vulnerability disclosure.
- Addresses information sharing and management of legacy devices.
- Intended to be adopted by member regulators, including in the UK, EU, US, Canada, Australia and Japan.
IMDRF guidance underpins national requirements, including those of the MHRA. UK medical device manufacturers and software developers should align product security processes to N60 to support approvals in multiple markets.
Source: IMDRF N60 Principles and Practices for Medical Device Cybersecurity (IMDRF)
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