The EU MDR / IVDR Transition Playbook

Chapter 1. Transition Strategy, Scope, and Governance

1.1 What MDR and IVDR Transition Must Achieve
1.2 Portfolio Scope, Legacy Certificates, and Market Exposure
1.3 Transition Pathways, Deadlines, and Decision Gates
1.4 Program Governance, Roles, and Workstream Cadence
1.5 Executive Dashboard and Transition Risk Register

Chapter 2. Gap Assessment and Remediation Roadmap

2.1 Current-State Diagnostic Across Product, QMS, and Markets
2.2 MDR and IVDR Gap Assessment Methodology
2.3 Product Prioritization, Rationalization, and SKU Decisions
2.4 Remediation Roadmap, Critical Path, and Resource Plan
2.5 Stage-Gate Reviews and Management Oversight

Chapter 3. Classification, Conformity Assessment, and QMS Readiness

3.1 MDR and IVDR Classification Rules and Borderline Issues
3.2 Conformity Assessment Routes and Certificate Strategy
3.3 QMS Upgrades for MDR and IVDR Compliance
3.4 Economic Operators, PRRC, and Distributor Controls
3.5 Internal Audit, Management Review, and Inspection Readiness

Chapter 4. Technical Documentation and Product Evidence Package

4.1 Technical File Architecture and Documentation Standards
4.2 General Safety and Performance Requirements Mapping
4.3 Risk Management, Benefit-Risk, and Usability Evidence
4.4 Labeling, IFU, UDI, and Claims Control

4.5 Technical Documentation Readiness Checklist

Chapter 5. Clinical Evaluation and IVDR Performance Evaluation

5.1 Clinical Evaluation Strategy for Medical Devices
5.2 Clinical Evidence Gaps, Equivalence, and Literature Review
5.3 IVDR Performance Evaluation Strategy and Evidence Model
5.4 Scientific Validity, Analytical Performance, and Clinical Performance
5.5 CER, PER, SSCP, and SSP Documentation Standards

Chapter 6. PMS, PMCF, PMPF, Vigilance, and Lifecycle Control

6.1 PMS System Design and Data Source Mapping
6.2 PMCF and PMPF Planning, Execution, and Reporting
6.3 PSUR, PMS Report, Trend Reporting, and Vigilance
6.4 Change Control, Significant Change, and Legacy Device Monitoring
6.5 Lifecycle Governance After MDR and IVDR Certification

Chapter 7. Notified Body Engagement and Submission Management

7.1 Notified Body Selection, Capacity, and Contracting Strategy
7.2 Submission Planning, Sequencing, and Dossier Packaging
7.3 Notified Body Question Management and Response Governance
7.4 Audit Preparation, Findings, CAPA, and Certification Closure
s7.5 EUDAMED, Registration, and Post-Certification Obligations

Chapter 8. Implementation Roadmap and External Support Options

8.1 Building the MDR / IVDR Transition Implementation Plan
8.2 Internal Capabilities, Resourcing, and Change Management
8.3 Support From Large Consulting Firms
8.4 Specialist Regulatory, Clinical, Quality, and Notified Body Advisors
8.5 Independent Management Consultants Through Umbrex