Syllabus
EU MDR and IVDR Compliance Certificate Program
39 lessons, about 16 hours. Online and self-paced, with a certificate when you finish.
Regulatory Framework and Transitions
Learners establish device regulatory applicability, assign economic operator responsibilities, and determine eligibility for the extended MDR and IVDR transitional arrangements.
- 1Regulatory Scope and Product Qualification
- 2MDR and IVDR Health-Institution Exemption Eligibility
- 3Economic Operator and PRRC Responsibilities
- 4MDR Legacy Device Transition Eligibility
- 5IVDR Transition Eligibility and Milestones
MDR and IVDR Device Classification
Learners classify MDR and IVDR products using legally applicable risk-based rules and prepare documented justifications that support subsequent conformity assessment decisions.
- 6MDR Annex VIII Classification
- 7IVDR Annex VIII Classification
- 8Classification Rationale and Assessment Pathways
- 9Classification Change-Impact Assessment
Quality, Risk, and Safety
Learners connect manufacturer quality systems, lifecycle risk management, safety and performance requirements, labeling, and software controls to documented regulatory compliance.
- 10Quality Management and Regulatory Interfaces
- 11Lifecycle Risk and Benefit Assessment
- 12Dual-Regulation GSPR Evidence Matrices
- 13Device Labeling, Implant Cards, and Electronic Instructions
- 14Medical Device Software Safety and AI Applicability
Technical Documentation Development
Learners create and evaluate separate MDR and IVDR Annex II and III technical documentation structures supported by traceable design, manufacturing, verification, validation, and lifecycle evidence.
- 15MDR Annex II Documentation Architecture
- 16IVDR Annex II Documentation Architecture
- 17Design and Manufacturing Evidence Traceability
- 18Verification and Validation Evidence Review
- 19Annex III Documentation and Retention
- 20Technical Documentation Gap Closure and Submission Readiness
MDR Clinical Evidence
Learners plan and critically evaluate MDR clinical evidence, determine clinical investigation requirements, and connect post-market clinical follow-up to ongoing clinical evaluation.
- 21Develop an MDR Clinical Evaluation Plan
- 22Clinical Literature and Equivalence Appraisal
- 23Clinical Investigation Applicability Decisions
- 24PMCF and Clinical Evidence Updates
IVDR Performance Evidence
Learners develop scientific validity, analytical performance, and clinical performance evidence while determining performance study pathways and maintaining post-market performance follow-up.
- 25Performance Evaluation Plans and Claims
- 26Scientific and Performance Evidence Reports
- 27Performance Study Regulatory Pathways
- 28PMPF and Performance Evaluation Updates
Conformity Assessment and Certification
Learners select conformity assessment procedures, prepare notified-body submissions, apply applicable exceptions, and manage certification findings and product changes.
- 29MDR and IVDR Conformity Routes
- 30Notified Body Submissions and Timelines
- 31Declarations, CE Marking, and Exceptions
- 32Notified Body Findings and Recertification
UDI, EUDAMED, and Transparency
Learners establish device identification, registration readiness, and safety and performance summary controls under the phased mandatory implementation of EUDAMED.
- 33UDI Assignment and Labeling Controls
- 34EUDAMED Registration and Transition Deadlines
- 35Safety and Performance Summary Publishing
Postmarket Surveillance and Vigilance
Learners establish a complete MDR and IVDR post-market operating system covering surveillance planning, statutory reporting, incident triage, field safety actions, regulatory change control, and supply interruption notifications.
- 36Postmarket Surveillance System Design
- 37PMS Reports and PSUR Preparation
- 38Complaint Triage and Incident Reporting
- 39Trends, Field Actions, and Supply Continuity