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.

Author

Denise McDermott, Senior Regulatory Compliance Specialist, Compliance & Risks

Denise McDermott is a senior regulatory compliance specialist on the Global regulatory compliance team at Compliance & Risks.

Prior to this she worked in the medical device industry for 13 years across a number of areas including regulatory affairs, post-market surveillance, customer complaints, quality, and technical support.

She has experience in several areas including IVDR, CE marking, labeling, customer and quality technical communications and regulatory risk assessments. Denise holds an honours degree in biochemistry and a Ph.D. in cancer biology.