European Union (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR) and Cybersecurity
Whitepaper Overview:
While technological advances in the medical device field bring a host of new opportunities for improved patient care, cybersecurity and data privacy challenges may occur. The European Union (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR) sets out conditions for maintaining high safety standards for IVDs, while taking into account potential technological progress into the future.
This whitepaper gives an overview of the regulatory landscape as regards medical devices and cybersecurity in the EU.
This Whitepaper Covers:
- EU In Vitro Diagnostic Regulation 2017/746 (IVDR) and cybersecurity
- Medical Device Coordination Group (MDCG) guidance documents on medical device cybersecurity
- International Medical Device Regulators Forum documents on medical device cybersecurity
- EU Legislation on cybersecurity and data protection
*This whitepaper was originally published on 4th October, 2023. Further regulatory developments may have occurred after publication. To keep up-to-date with the latest compliance news, sign up to our newsletter.
