MDR (EU Medical Device Regulation 2017/745) Essentials Training by Tonex
Navigate MDR with confidence as you learn how regulations translate into day-to-day engineering, quality, and regulatory actions. From classification through CE marking, you will build the documentation, evidence, and processes expected by notified bodies. The program clarifies how technical files, clinical evaluation, and PMS connect to risk management and QMS.
Cybersecurity receives focused attention because networked and software-driven devices must resist unauthorized access, data loss, and safety-critical manipulation. You will learn secure-by-design practices, vulnerability handling, and update controls aligned to GSPR and lifecycle evidence so product safety and performance remain defensible after release.
Learning Objectives
- Understand MDR structure, actors, and obligations
- Apply Annex VIII rules to classify devices consistently
- Prepare technical documentation and clinical evaluation reports that pass review
- Implement UDI, EUDAMED readiness, PMS, PMCF, and vigilance processes
- Align ISO 13485 and ISO 14971 to MDR deliverables and audits
- Prove cybersecurity measures within MDR evidence using the word cybersecurity properly in planning and reporting
Audience
- Regulatory Affairs Specialists
- Quality Assurance Managers
- R&D and Product Engineers
- Clinical and Safety Professionals
- Cybersecurity Professionals
- Compliance Officers and Auditors
- Project and Program Managers
- Manufacturers, Importers, Distributors
Course Modules
Module 1 – MDR Foundations
- Scope and key definitions
- Roles of manufacturer and AR
- Notified body expectations
- CE marking pathway steps
- Legacy vs new devices
- Market surveillance duties
Module 2 – Device Classification
- Using Annex VIII structure
- Interpreting individual rules
- Software rule 11 decisions
- Accessory and borderline logic
- Reusable surgical instruments
- Documentation of rationale
Module 3 – GSPR and Risk
- Annex I layout and intent
- Safety and performance linkage
- Usability and human factors
- Electrical and software safety
- Cybersecurity and update control
- Traceability to risk controls
Module 4 – Technical Documentation
- Device description and variants
- Design and manufacturing records
- Verification and validation evidence
- IFU, labeling, and UDI artifacts
- Clinical evaluation integration
- Change control and releases
Module 5 – Clinical, PMS, PMCF
- CER plan, appraisal, synthesis
- Equivalence and literature strategy
- PMCF studies and surveys
- Vigilance, trend, field actions
- PSUR structure and cadence
- EUDAMED data and submissions
Module 6 – QMS and Audits
- ISO 13485 alignment mapping
- ISO 14971 risk integration
- Supplier control and purchasing
- CAPA with effectiveness checks
- Internal audit preparation
- Audit defense communication
Advance your MDR readiness with clear steps, practical templates, and audit-proof reasoning. Join Tonex to convert regulatory text into repeatable processes, strengthen security evidence, and accelerate EU market access. Enroll now and build confident, compliant teams.