Medical device - MDR and IVDR Compliance
Understanding MDR and IVDR Cybersecurity Regulations
The Medical Device Regulation (MDR) 2017/745 and In-Vitro Diagnostic Regulation (IVDR) 2017/746 introduce stringent cybersecurity requirements for medical devices incorporating electronic programmable systems and software. Under these regulations, software itself can be classified as a medical device, necessitating compliance with robust cybersecurity measures to mitigate risks related to data security, unauthorized access, and device functionality.
Manufacturers are required to design and develop medical devices that align with the state of the art in cybersecurity while maintaining a comprehensive risk management approach throughout the product life cycle. The primary goal is to protect patient safety and data integrity while ensuring operational security against potential cyber threats.
Key Cybersecurity Requirements Under MDR and IVDR
Annex I – General Safety and Performance Requirements (GSPR)
Annex I of both MDR and IVDR outlines cybersecurity obligations, including:
Risk management related to information security and protection against unauthorized access.
Implementation of appropriate security measures to ensure device performance and data integrity.
Ensuring interoperability, repeatability, and reliability of software-based medical devices.
Developing and manufacturing devices in compliance with state-of-the-art cybersecurity principles.
Safeguarding against foreseeable security threats throughout the product life cycle.
Regulatory Guidance for Cybersecurity Compliance
To support compliance, the Medical Device Coordination Group (MDCG) has published guidance documents, including:
MDCG 2019-16 – Provides recommendations for cybersecurity activities throughout the device life cycle.
MDCG 2019-11 – Guides the qualification and classification of software under MDR and IVDR.
Additionally, medical device manufacturers must consider broader European cybersecurity and data protection regulations, including:
General Data Protection Regulation (GDPR) (EU) 2016/679 – Governs the handling and protection of personal data.
NIS 2 Directive (EU) 2022/2555 – A comprehensive cybersecurity framework applicable to healthcare entities.
Implementing Cybersecurity Across the Device Life Cycle
To ensure compliance with MDR and IVDR, cybersecurity must be integrated at every stage of the device life cycle:
1. Design and Development
Medical devices must be secure by design, incorporating security features from the initial development phase. Key considerations include:
Secure coding practices.
Encryption of sensitive data.
Network and software access controls.
2. Risk Management and Control Measures
A robust risk management system should be established to:
Identify and evaluate potential cybersecurity threats.
Implement security controls that mitigate identified risks.
Continuously monitor and update security measures based on emerging threats.
3. Verification and Validation Testing
Annex I of MDR mandates that medical devices undergo comprehensive verification and validation testing, including:
Security feature testing.
Vulnerability assessments and penetration testing.
Evaluation of software resilience against cyber threats.
4. Post-Market Surveillance and Cybersecurity Updates
Manufacturers must ensure continuous monitoring of cybersecurity risks post-market. Key activities include:
Implementing security updates and patches.
Monitoring emerging cyber threats and adapting security protocols accordingly.
Addressing vulnerabilities through structured post-market surveillance (PMS) processes.
Key Cybersecurity Principles for Compliance
To align with MDR and IVDR cybersecurity requirements, manufacturers must implement a layered security approach, including:
Security Management: Developing policies and frameworks for cybersecurity governance.
Defense-in-Depth Strategy: Deploying multiple security layers to prevent unauthorized access.
Data Protection and Encryption: Ensuring sensitive data is protected against breaches.
Incident Response and Recovery: Establishing response mechanisms for cybersecurity incidents.
While robust cybersecurity measures are essential, they must be carefully balanced to avoid compromising device functionality. Overly restrictive security controls can impact the usability of medical devices, particularly in emergency healthcare settings. Therefore, manufacturers should adopt risk-based cybersecurity measures tailored to the device’s intended use and user environment.
Related Services
Click here to know about the Radio Compliance ACMA
Click here to know about the Telecommunication Compliance ACMA
Click here to know everything about GEMS MEPS Compliance
Click here to know everything about EME/EMR Compliance
Click here to know everything about ERAC/EESS Compliance
Other Services
Click here to know about the Approval Process for the Canadian Market
Click here to know about the SRCC certifications
Click here to know everything about European Type Approval
Click here to know everything about Type Approval for Fiji
Click here to know everything about Type Approval for Hong Kong
Click here to know everything about India Approvals
Click here to know everything about Type Approval for Japan
Click here to know everything about Type Approval for Malaysia
Click here to know everything about Type Approval for Russia
Click here to know everything about Type Approval for Saudi Arabia
Click here to know everything about Type Approval for South Africa
Click here to know everything about Type Approval for Singapore
Click here to know everything about Type Approval for South America
Click here to know everything about Type Approval for South Korea
Click here to know everything about NCC Certificate
Click here to know everything about BSMI Mark
Click here to know everything about Type Approval for USA
Company Strengths at a glance
Why C-PRAV?
We adapt our services to your specific product needs, providing practical and efficient compliance solutions.
By partnering with C-PRAV, manufacturers can streamline their cybersecurity compliance processes, mitigate risks, and confidently bring their medical devices to market while adhering to MDR and IVDR regulations.
We offer comprehensive services tailored to all risk levels, from low to high, ensuring thorough testing, documentation, and quick turnaround times to get your product to market faster. Beyond certification, we provide ongoing support to help you navigate evolving regulations, all at competitive pricing that maximizes your investment in compliance.
Choose Compliance, Choose Certifications, Choose C-PRAV with Confidence!
We Have Great Answers
Ask Us Anything
Medical device manufacturers must ensure devices incorporate risk management, information security, protection against unauthorized access, and verification and validation of cybersecurity measures.
Annex I of MDR classifies cybersecurity as part of the General Safety and Performance Requirements (GSPR), requiring devices with electronic programmable systems and software to meet strict security standards.
Manufacturers must conduct verification and validation testing, including security feature testing, vulnerability assessments, penetration testing, and risk-benefit analysis.
GDPR enforces strict requirements on data protection and privacy, requiring medical devices to implement robust security measures to safeguard personal health information.
The NIS 2 Directive enhances cybersecurity resilience by imposing obligations on essential entities, including medical device manufacturers, to improve incident response and risk management strategies.
Yes, software that qualifies as a medical device under MDR and IVDR must comply with all cybersecurity and risk management requirements.
Regulatory Updates
European Cyber Resilience Act (CRA)
The European Cyber Resilience Act (CRA) establishes a robust legal framework to enhance the cybersecurity of hardware and software products with digital elements in the European Union (EU). Designed to address the increasing prevalence of cyberattacks and vulnerabilities in connected devices, the CRA sets clear and enforceable requirements for manufacturers,
FCC Selects Lead Administrator for Cybersecurity Label Program
The Public Safety and Homeland Security Bureau (Bureau) announces the selection of UL LLC (UL Solutions) to serve as both the Lead Administrator as well as a Cybersecurity Label Administrator (CLA) for the Federal Communications Commission’s (FCC or Commission) Internet of Things Cybersecurity Labeling Program (IoT Labeling Program) which includes the U.S. government
Cyber Resilience Act: Council Approves New Legislation for Digital Products
The Council approved new legislation on cybersecurity requirements for products with digital components, aimed at ensuring the safety of items like connected home cameras, refrigerators, TVs, and toys before they are introduced to the market (Cyber Resilience Act), on 10th Oct 2024. The new legislation, targeting manufacturers, distributors, and importers of