1. Introduction

The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) present stringent documentation expectations. A modern Document Management Software is essential for managing technical files, risk assessments, validation documents, and post‑market surveillance artifacts, especially in the context of Document Management, document version control software, and employee training management software.

2. EU MDR/IVDR Requirements

• Documentation must be maintained and up to date for the entire lifecycle.

• Changes to device design, labeling, or risk assessment require controlled updates.

• Training records must show personnel competency on processes related to device manufacture or testing.

• Technical files and clinical evaluation reports must be immediately retrievable for Notified Bodies or regulators.
  
  

3. Key DMS Features for MDR/IVDR

3.1 Technical File & Documentation Library

A structured repository where design plans, risk assessments, validation reports, and labeling files are stored with metadata.

3.2 Version Control and Change Logs

Document version control software ensures any updates to risk-management files, device specs, or SOPs are tracked, approved, and retrospectively traceable.

3.3 Review and Approval Workflow

Each document can have multi‑level review, review reminders, digital signatures, and final release logs. This ensures conformity to procedural rules.

3.4 Training Integration

When documents are revised (e.g. a risk assessment updated), employee training management software assigns relevant training tasks to impacted staff—and tracks completion and proficiency.

4. Connecting DMS to Post‑Market Surveillance

• Post‑market data, vigilance reports, or trends feed into DMS.

• Corrective actions lead to updated SOPs or labeling, triggering new training and re‑release procedures.
  
  

5. Benefits for MDR/IVDR Compliance

• Audit readiness: Notified Bodies can be furnished full technical files on demand.

• Traceability: Documentation of changes, rationale, responsible persons, and approvals.

• Consistency: All stakeholders use the latest documents.

• Training compliance: Staff are trained on any updates, ensuring process adherence.
  
  

6. Implementation Steps

1. Identify all regulatory documentation requirements for the device lifecycle.

2. Categorize the documents and set metadata standards.

3. Deploy DMS with robust version control and workflow capabilities.

4. Integrate with training modules to ensure staff read and acknowledge changes.

5. Conduct audits and mock inspections to test retrievability and completeness.
   
   

7. Common Pitfalls and Avoidance

• Duplicate uncontrolled copies: limit offline printing and shared drive duplication.

• Neglected training updates: automatically enforce training completion before putting new documents into practice.

• Manual tracking gaps: rely on dashboards and automated reminders within the system.
  
  

8. Example Scenario

A device manufacturer needs to update labeling due to post‑market findings:

• A risk assessment is revised in the DMS, triggering version increment.

• The change-control workflow is initiated, reviewed, and approved.

• The updated labeling document is published.

• Employee training management software notifies impacted roles to complete reading and acknowledgment.

• Training logs are captured.

• All artifact history—from risk assessment changes to retraining—is available for audit.
  
  

9. Why Document Version Control Software Is Vital

Especially within MDR/IVDR, reviewers must know which version of a risk file or clinical evaluation was in force at any point in time. This is only possible with robust versioning that tracks changes, reviewers, timestamps, and rationale.

10. Conclusion

For companies subject to EU MDR and IVDR, employing best‑in‑class Document Management Software with built‑in document version control software and integrated employee training management software is not optional—it’s essential. It ensures compliant technical file management, audit readiness, version traceability, and training compliance. ComplianceQuest provides purpose‑built solutions tailored to these regulatory regimes to simplify compliance while safeguarding quality and traceability.