Everything You Need to Know About the New Essential Principles<\/p>\n\n\n\n
What is New in the 2024 Version?<\/strong><\/p>\n\n\n\n The updated document focuses on modern challenges like:<\/p>\n\n\n\n Essential Principles are basic rules that every medical device must follow.<\/p>\n\n\n\n When a device follows these rules, it means:<\/p>\n\n\n\n Think of it this way: Just like a car must have brakes, airbags, and seatbelts to be safe, a medical device must meet these Essential Principles to be approved for sale.<\/p>\n\n\n\n Change 1: Cybersecurity is Now Mandatory (EP 5.8.5)<\/strong><\/p>\n\n\n\n What the document says: What this means for you:<\/strong><\/p>\n\n\n\n Create a cybersecurity risk management plan for every device with software.<\/strong><\/p>\n\n\n\n Change 2: Devices for Ordinary People (Lay Users) (EP 5.12)<\/strong><\/p>\n\n\n\n What the document says:<\/strong> What this means for you:<\/strong><\/p>\n\n\n\n Test your device with real ordinary people, not just trained professionals.<\/strong><\/p>\n\n\n\n Change 3: Safety Must Be Tracked Throughout Product Life (EP 5.1.2f)<\/strong><\/p>\n\n\n\n What the document says:<\/strong> What this means for you:<\/strong><\/p>\n\n\n\n Create a system where post-market data regularly updates your risk management file.<\/strong><\/p>\n\n\n\n Here is a simple table showing which standards help you meet each Essential Principle.<\/p>\n\n\n\n For All Medical Devices and IVDs<\/strong><\/p>\n\n\n\n For Medical Devices Only (Non-IVD)<\/strong><\/p>\n\n\n\n For IVD Medical Devices Only<\/strong><\/p>\n\n\n\n Compare your current processes against all Essential Principles. Mark what you already do and what is missing.<\/p>\n\n\n\n Add cybersecurity threats, usability risks, and post-market data to your risk file.<\/p>\n\n\n\n Make sure your clinical evidence clearly shows benefits outweigh risks.<\/p>\n\n\n\n Check if your instructions are easy to understand, especially for home-use devices.<\/p>\n\n\n\n Create a system where post-market data flows back into your risk management.<\/p>\n\n\n\n At Satori One Click Solutions LLP, we support medical device and IVD manufacturers at every stage of the product lifecycle – from concept to post-market.<\/p>\n\n\n\n Design and Development<\/strong><\/p>\n\n\n\n Quality Management System (QMS)<\/strong><\/p>\n\n\n\n Clinical Evaluation<\/strong><\/p>\n\n\n\n Labeling and Instructions for Use<\/strong><\/p>\n\n\n\n Regulatory Strategy and Marketing Authorization<\/strong><\/p>\n\n\n\n Post-Market Surveillance<\/strong><\/p>\n\n\n\n Recall Management<\/strong><\/p>\n\n\n\n Continuous Improvement<\/strong><\/p>\n\n\n\n Why Choose Satori One Click Solutions LLP?<\/strong><\/p>\n\n\n\n\n
2. What Are Essential Principles<\/h2>\n\n\n\n
Requirement<\/th> What It Means<\/th><\/tr><\/thead> Safe<\/td> No unacceptable risk to patients or users<\/td><\/tr> Effective<\/td> Does what it is supposed to do<\/td><\/tr> Reliable<\/td> Works properly throughout its expected lifetime<\/td><\/tr> Compatible<\/td> Works correctly in its intended environment<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n 3. Who Needs to Read This Document?<\/h2>\n\n\n\n
Person or Role<\/th> Why They Need It<\/th><\/tr><\/thead> Manufacturers<\/td> To design safe and compliant products<\/td><\/tr> Regulatory Authorities<\/td> To check if products are safe before approval<\/td><\/tr> Quality Managers<\/td> To update their quality systems<\/td><\/tr> Software Engineers<\/td> To build secure medical software<\/td><\/tr> Clinical Teams<\/td> To plan proper clinical tests<\/td><\/tr> Labeling Teams<\/td> To write correct instructions for use<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n 4. The Three Biggest Changes from 2012<\/h2>\n\n\n\n
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<\/strong>“The medical device should provide an adequate level of cybersecurity against attempts to gain unauthorized access.”<\/p>\n<\/blockquote>\n\n\n\n\n
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“Devices for use by lay users should perform appropriately taking into account the skills and means available to lay users.”<\/p>\n<\/blockquote>\n\n\n\n\n
“Evaluate the impact of information from production and post-production phases on overall risk.”<\/p>\n\n\n\n\n
5. Standards for Each Essential Principle<\/h2>\n\n\n\n
EP Number<\/th> Topic<\/th> Main Standards<\/th><\/tr><\/thead> 5.1<\/td> Risk Management and Quality Management Systerm for Medical Devices<\/td> ISO 13485, ISO 14971<\/td><\/tr> 5.2<\/td> Clinical Evaluation<\/td> ISO 14155<\/td><\/tr> 5.3<\/td> Biological Safety<\/td> ISO 10993 Series<\/td><\/tr> 5.4<\/td> Sterilization<\/td> ISO 11135, ISO 11137, ISO 17665<\/td><\/tr> 5.5<\/td> Environment and Use<\/td> IEC 60601, IEC 62366-1<\/td><\/tr> 5.6<\/td> Electrical and Mechanical Safety<\/td> IEC 60601, IEC 61010<\/td><\/tr> 5.7<\/td> Active Devices<\/td> IEC 60601, IEC 61010<\/td><\/tr> 5.8<\/td> Software and Cybersecurity<\/td> IEC 62304<\/td><\/tr> 5.9<\/td> Measuring Functions<\/td> IEC 60601, IEC 61010<\/td><\/tr> 5.10<\/td> Labeling<\/td> ISO 20417, ISO 15223-1<\/td><\/tr> 5.11<\/td> Radiation<\/td> IEC 60601, IEC 61010<\/td><\/tr> 5.12<\/td> Lay User Devices<\/td> IEC 62366-1<\/td><\/tr> 5.13<\/td> Biological Materials<\/td> ISO 22442<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n EP Number<\/th> Topic<\/th> Main Standards<\/th><\/tr><\/thead> 6.1<\/td> Material Properties<\/td> ISO 10993, IEC 60601<\/td><\/tr> 6.2<\/td> Imaging Radiation<\/td> IEC 60601<\/td><\/tr> 6.3<\/td> Implants<\/td> Device-specific<\/td><\/tr> 6.4<\/td> Energy and Substance Supply<\/td> IEC 60601<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n EP Number<\/th> Topic<\/th> Main Standards<\/th><\/tr><\/thead> 7.1<\/td> IVD Material Properties<\/td> CLSI EP Series, ISO 17511<\/td><\/tr> 7.2<\/td> IVD Performance<\/td> ISO 10993, IEC 61010<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n 6. How to Implement: Five Simple Steps<\/h2>\n\n\n\n
Step 1: Gap Assessment<\/strong><\/h3>\n\n\n\n
Step 2: Update Risk Management File<\/strong><\/h3>\n\n\n\n
Step 3: Strengthen Clinical Evaluation<\/strong><\/h3>\n\n\n\n
Step 4: Review Labeling<\/strong><\/h3>\n\n\n\n
Step 5: Close the Post-Market Surveillance Loop<\/strong><\/h3>\n\n\n\n
7. Key Takeaways<\/h2>\n\n\n\n
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8. Final Thoughts<\/h2>\n\n\n\n
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9. How We Can Help<\/h2>\n\n\n\n
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