13 October 2026, 09:57 PM
Medical devices are getting more connected every day. This makes them easier to use and manage. It also brings new risks. A cyberattack could change test results, make a device stop working, or put safety in danger.
In Europe, the MDCG cybersecurity guidance helps medical device manufacturers understand how to address cybersecurity rules under the MDR and IVDR. The guidance, called 2019 16 Rev.1, does not create new laws. Rather than it explains what is already required by law.
Cybersecurity is about finding security flaws in a device. It means thinking about security from the start of development. Manufacturers must stay alert to threats. Fix problems even after the device is on the market.
In this guide, you will learn what manufacturers need to know about the guidance. It also tells you how to follow its recommendations in real situations.
What Is MDCG 2019-16 Cybersecurity Guidance?
The Medical Device Coordination Group released 2019 16 Rev.1 in July 2020. 2019 16 gives clear recommendations for applying cybersecurity rules under EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).
Two sections of MDR Annex I are particularly relevant:
Section 17.2 Covers :
Manufacturers can refer to standards and current technical practices when deciding how to meet these requirements and document their work.
The document also discusses the roles of integrators, healthcare organisations, operators, healthcare professionals, and patients.
Source: https://qualysec.com/mdcg-cybersecurity-guidance/
In Europe, the MDCG cybersecurity guidance helps medical device manufacturers understand how to address cybersecurity rules under the MDR and IVDR. The guidance, called 2019 16 Rev.1, does not create new laws. Rather than it explains what is already required by law.
Cybersecurity is about finding security flaws in a device. It means thinking about security from the start of development. Manufacturers must stay alert to threats. Fix problems even after the device is on the market.
In this guide, you will learn what manufacturers need to know about the guidance. It also tells you how to follow its recommendations in real situations.
What Is MDCG 2019-16 Cybersecurity Guidance?
The Medical Device Coordination Group released 2019 16 Rev.1 in July 2020. 2019 16 gives clear recommendations for applying cybersecurity rules under EU Regulations 2017/745 (MDR) and 2017/746 (IVDR).
Two sections of MDR Annex I are particularly relevant:
Section 17.2 Covers :
- Software development
- Risk management
- Information security
- Verification
- Validation
- Specify the hardware
- Network conditions
- IT security measures needed for the device to operate as intended
Manufacturers can refer to standards and current technical practices when deciding how to meet these requirements and document their work.
The document also discusses the roles of integrators, healthcare organisations, operators, healthcare professionals, and patients.
Source: https://qualysec.com/mdcg-cybersecurity-guidance/