Intermediate2h 15m # EU MDR Certification Course (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. Getting classification wrong, treating a clinical evaluation report as a formality, or backfilling technical documentation the week before a notified body submission are the ordinary, recurring ways medical device companies lose months, and sometimes their entire EU market access, to an avoidable deficiency finding. None of this is exotic. It's a process problem, and it's fixable with the right framework applied from the first day of development, not the last. This course teaches EU Medical Device Regulation 2017/745 from first principles to complete practical compliance: whether your product meets the Article 2 device definition and how the twenty two classification rules in Annex Eight sort it into a risk class, every economic operator role the regulation creates including the EU authorised representative and the Person Responsible for Regulatory Compliance, which conformity assessment route applies to your class and how notified bodies actually review a file, the General Safety and Performance Requirements and the harmonized standards that satisfy them, how to build technical documentation under Annex Two and Annex Three that survives real scrutiny, how to stand up an ISO 13485 quality management system, clinical evaluation and clinical investigations 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 overlap with the EU AI Act and MDCG cybersecurity guidance, UDI, labeling, and the EUDAMED database including its 2026 mandatory modules, post-market surveillance and vigilance reporting timelines, and the 2027 and 2028 legacy device transition deadlines under Regulation 2023/607. Every module ends with a knowledge check, and the final modules walk a realistic connected medical device through the entire compliance process end to end before turning what you've learned into your own compliance action plan and calendar. Common failure patterns — mismatched classifications, stale clinical evaluations, missed periodic safety update reports — are covered as they occur throughout the course, not just listed once at the end. Built on Krono's regulatory database and current 2026 MDCG guidance, EUDAMED rollout status, and transition deadlines. This course contains the use of artificial intelligence for asthetic purposes. * Includes the ebook edition, free * 8 downloadable resources included ## What you'll learn * 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 ## Requirements * ·No prior EU regulatory experience required — the course starts from first principles * ·Some familiarity with medical device engineering, quality, or product development is helpful but not essential * ·Founders, regulatory affairs staff, quality engineers, and device engineering leads will all benefit $199.00 One-time purchase · Lifetime access · No subscription Less than one hour with a compliance consultant. [First lesson free to preview: EU Medical Device Regulation (MDR 2017/745)](#lesson-19e25f3f-f466-472f-816c-9de240be2e11) * 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 Includes the ebook edition, free — read it in your [library](/platform/books) after purchase. Enroll — $199.00 Secure checkout via Paddle Not what you expected? Contact us within 14 days. Built from a regulatory graph already at work 1,600 users this week 658 guides 323 product types 9 markets ## Course content 18 modules·135 min total EU Medical Device Regulation: The Big Picture Preview9 min Is Your Product a Medical Device? Scope and Definitions 8 min Risk Classification: Annex VIII and the 22 Rules 9 min Economic Operators: Manufacturer, Authorised Representative, Importer, Distributor, PRRC 8 min Conformity Assessment Routes and Notified Bodies 10 min General Safety and Performance Requirements and Harmonized Standards 8 min Technical Documentation: Annex II and Annex III 7 min Quality Management Systems: ISO 13485 and Article 10 8 min Clinical Evaluation and Clinical Investigations 8 min Testing and Evidence: Biocompatibility, Safety, Software, Usability 9 min Software, SaMD, and AI Under MDR 8 min UDI, Labeling, and EUDAMED 9 min Post-Market Surveillance, Vigilance, and PSUR/PMCF 8 min The MDR Transition: Legacy Devices and Deadlines 8 min Common Failures, Full Walkthrough, and Your Action Plan 8 min Your Compliance Action Plan 8 min Closing Thoughts 1 min What's Next 0 min Enroll — $199.00 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. 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