Cybersecurity

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The new EU Cybersecurity Directive NIS2 replaces the previous EU Network and Information Security Directive (NIS Directive). The goal is to ensure a common level of cybersecurity across the Union. The national Cyber Security Act 124/2025, which implements the NIS2 directive, came into force on April 8, 2025.  Fimea supervises, based on cybersecurity legislation, among others, manufacturers of medicines and medical devices as well as blood service operators. 

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