Cybersecurity according to Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostics Regulations (IVDR) (EU) 2017/746
Medical Device Software Uncertainties
General Background
Cybersecurity in Medical Device Software
The European Union’s Medical Devices Regulation (EU MDR) has several cybersecurity considerations for medical device manufacturers. These considerations are aimed at ensuring the security and privacy of patient data and protecting against cyber threats that could compromise the safety and performance of medical devices.
Some of the cybersecurity considerations of the EU MDR are:
Manufacturers must assess and manage the risks associated with cybersecurity threats that could affect the safety and performance of their medical devices. This includes considering potential threats to data privacy, as well as threats to the availability and integrity of the device itself.
Manufacturers must incorporate appropriate technical measures into their devices to ensure that they are secure and protected against cyber threats. These measures may include encryption, access controls, and other security features.
Manufacturers must establish, document, implement, maintain, and update an Information security management system that includes appropriate cybersecurity policies and procedures.
Manufacturers must have procedures in place to report incidents related to cybersecurity threats or breaches. This includes reporting incidents to relevant authorities, such as national cybersecurity agencies.
Manufacturers must perform a clinical evaluation of their devices, taking into account cybersecurity risks and potential impacts on patient safety and privacy.
Manufacturers must establish a post-market surveillance system that includes procedures for monitoring cybersecurity risks and incidents.
Additionally, MDCG 2019-16, a guidance document published by the European Commission’s Medical Device Coordination Group (MDCG) that provides recommendations on the cybersecurity of medical devices. The guidance is intended to help manufacturers, notified bodies, and other stakeholders understand the cybersecurity requirements of the EU MDR and EU IVDR. MDCG 2019-16 lays out eight most necessary processes that should be in place for in-depth defense strategy throughput the device’s lifecycle:
Security management
Defense strategy
Manufacturers are expected to provide are product specifications related to recommended cybersecurity controls appropriate for the intended use environment, device features that protect critical functionality, description of backup and restore feature, infrastructure requirements, secure configurations, the list of network ports and other interfaces.
The holistic cybersecurity strategy is documented in the risk management file.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key points
Manufacturers should consider the following principles:
Our Services
Training
AKRA TEAM offers training on cybersecurity to meet the expectations of EU MDR and EU IVDR. This will ensure that your personnel have the appropriate training, knowledge, and qualifications to implement cybersecurity system for your device.
Process and Templates Development
AKRA TEAM can assist in creating required processes to ensure conformity, as well as creating appropriate templates to provide compliance with the cybersecurity requirements.
Gap Assessment
AKRA TEAM can evaluate and assess the quality, completeness, and conformity of the relevant documents. Documentation will be compared against cybersecurity requirements to ensure conformity of the product(s). AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM helps in defining the ideal regulatory strategy for implementing the extent of security control, IT security measures, and data protection. AKRA TEAM can also help in creating the required documentation and assistance during conformity assessment.
Continuous update of documentation
AKRA TEAM additionally offers solutions for continuous documentation updates and review of cybersecurity documentation. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained.
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