E-Book26 chapters # EU MDR 2017/745 Certification Handbook An EU MDR 2017/745 handbook: device classification, economic operators, conformity routes, notified bodies, GSPRs, clinical evaluation and post-market duties. Most medical device companies encounter the EU Medical Device Regulation the way it hurts most: mid-development, with a launch date already promised and a notified body queue longer than anyone budgeted for. This book is built to prevent that collision. It walks through Regulation 2017/745 from first principles to complete practical compliance: whether your product meets the Article 2 device definition and how the twenty two Annex VIII rules classify it, every economic operator role from manufacturer to PRRC, which conformity assessment route applies to your class and what a notified body actually reviews, the General Safety and Performance Requirements and the harmonized standards that satisfy them, building technical documentation and an ISO 13485 quality system that survive real scrutiny, clinical evaluation under the MDR's much stricter equivalence rules, the full testing programme across biocompatibility, electrical safety, software, and usability, software and AI-specific obligations including the EU AI Act overlap, UDI, labeling and EUDAMED including its 2026 mandatory modules, and the post-market surveillance, vigilance, and legacy device transition deadlines running through 2027 and 2028. Every chapter closes with a knowledge check drawn from the companion video course, and eight appendices turn the book's worksheets into templates you can put to work on your own product immediately. This book contains the use of artificial intelligence. ## What you'll learn * Determine whether your product is an MDR-regulated device and how it gets classified under Annex VIII * Assign every economic operator role correctly — manufacturer, EU authorised representative, importer, PRRC * Choose the right conformity assessment route and know exactly what a notified body reviews and when * Build technical documentation, a GSPR compliance matrix, and an ISO 13485 QMS that survive real audit * Run a defensible clinical evaluation and know precisely when a clinical investigation is actually required * Scope a complete testing programme across biocompatibility, electrical safety, software, and usability * Handle UDI, EUDAMED registration, labeling, and the 2026 mandatory EUDAMED modules correctly * Meet post-market surveillance, vigilance, and PSUR obligations, and navigate the 2027/2028 transition deadlines $24.99 One-time purchase · Read in browser · No subscription * Determine whether your product is an MDR-regulated device and how it gets classified under Annex VIII * Assign every economic operator role correctly — manufacturer, EU authorised representative, importer, PRRC * Choose the right conformity assessment route and know exactly what a notified body reviews and when Buy for $24.99 Secure checkout via Paddle Not what you expected? Contact us within 14 days. This book is included free when you enroll in the full course — [$199.00 for the complete video curriculum plus this book](/courses/19-eu-medical-device-regulation-mdr-2017-745). Built from a regulatory graph already at work 1,600 users this week 658 guides 323 product types 9 markets ## Chapters Read Chapter 1 free → 1 The Big Picture: Why the MDR Isn't Optional Paperwork Before any classification lookup or documentation checklist, it's worth sitting with why this regulation carries the weight it does, and exactly where things… 2 Is Your Product a Medical Device? Scope and Definitions This chapter is the one every later decision in this book depends on. 3 Risk Classification: Annex VIII and the 22 Rules Classification is the single decision every other obligation in this book scales against. 4 Economic Operators: Who Carries Which Obligation The MDR regulates every company that touches a device on its way to a patient, not just the manufacturer. 5 Conformity Assessment Routes and Notified Bodies Your class determines your door: self-certification, or a notified body engaging under Annex IX, or Annex X plus XI. 6 General Safety and Performance Requirements and Harmonized Standards Annex I is the actual safety bar; harmonized standards are how nearly every manufacturer clears it without reinventing the proof from scratch. 7 Technical Documentation: Annex II and Annex III This is the file a notified body spends the most time inside. 8 Quality Management Systems: ISO 13485 and Article 10 A brilliant device with no functioning quality system behind it will eventually fail audit. 9 Clinical Evaluation and Clinical Investigations Notified body reviewers report that files fail here more than anywhere else. 10 Testing and Evidence: Biocompatibility, Safety, Software, Usability This chapter maps every testing domain that could apply to your device, and how to determine which genuinely do. 11 Software, SaMD, and AI Under MDR Software-only devices are the fastest-growing MDR category, and the EU AI Act now layers directly on top for a growing share of them. 12 UDI, Labeling, and EUDAMED Your technical file, clinical evidence, and quality system all eventually surface here: a code on the device, a label and instructions, and a central EU data… 13 Post-Market Surveillance, Vigilance, and PSUR/PMCF Certification begins an ongoing legal relationship with your device, not the end of one. 14 The MDR Transition: Legacy Devices and Deadlines The extended transition deadlines introduced by Regulation 2023/607 are conditional, not automatic. 15 Common Failures and a Full Device Walkthrough Nearly every serious MDR failure traces back to one of four recurring root causes. 16 Your Compliance Action Plan This chapter turns the entire book into a sequence you can actually put on a calendar, and points you to real resources for the questions specific to your ow… 17 What's Next You now have the complete framework this book set out to build: scoping, classification, economic operators, conformity assessment, technical documentation, … 18 Knowledge Checks Every module in this book closes with a knowledge check in the companion video course. 19 Appendix A — Device Scoping & Annex VIII Classification Worksheet 20 Appendix B — Economic Operators & Conformity Assessment Route Selector 21 Appendix C — GSPR Compliance Matrix & Technical Documentation Checklist 22 Appendix D — ISO 13485 Quality Management System Readiness Checklist 23 Appendix E — Clinical Evaluation & PMCF Planning Worksheet 24 Appendix F — Testing Plan Worksheet — Biocompatibility, Electrical Safety, Software, Usability 25 Appendix G — UDI, Labeling & EUDAMED Registration Checklist 26 Appendix H — Post-Market Surveillance, Vigilance & Transition Compliance Calendar Buy for $24.99 ## Want the full video course? This book's companion course covers the same material with video lessons and downloadable resources — and includes this book free. [ ![EU MDR Certification Course (MDR 2017/745)](/posters/19-eu-medical-device-regulation-mdr-2017-745.svg) ](/courses/19-eu-medical-device-regulation-mdr-2017-745) Intermediate2h 15m [ ### EU MDR Certification Course (MDR 2017/745) ](/courses/19-eu-medical-device-regulation-mdr-2017-745) EU MDR 2017/745 certification step by step: Annex VIII classification, notified bodies, GSPRs, technical file, clinical evaluation, QMS and post-market. Includes the ebook, free $199.00[View course →](/courses/19-eu-medical-device-regulation-mdr-2017-745) Need more than one? The **All-Access Krono Vault** unlocks every course and book for one payment, or put your whole team on it with **Krono Team Vault**. [See pricing](/pricing) Short on time? ### Rather hand it over than learn it? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. [See services](/services)