The European Union is awash with an alphabet soup of regulations that relate in full or part to cybersecurity and digital safety - from the long-established GDPR to the newly adopted NIS 2 and upcoming CRA.
Decoding The Cyber Alphabet Soup
CRA: The Cyber Resilience Act is a proposed EU horizontal regulation aimed at improving the cybersecurity...
Medtech companies must also comply with cybersecurity measures detailed in the MDR/IVDR and interpreted in guidance from the Medical Device Coordination Group document 2019-16, rev.1 guidance on cybersecurity.