IMDRF Announces non-IVD MA ToC Updates

The International Medical Device Regulators Forum (IMDRF) have released several key updates and reorganization changes to the non-IVD MA ToC in Editions 4, reflecting significant alterations in content and structure compared to the previous Index Verification Document (IVD) Table of Contents (ToC).

Notable Changes in the non-IVD ToC:

Chapter 2:

Sections removed from Chapter 3 and added to Chapter 2 in the new edition:

• • 2.07 Post-Market Study Plans
  • 2.08 Risk Management
  • 2.09 Essential Principles (EP) Checklist
  • 2.10 Standards
  • 2.10.01 List of Standards and Guidance Documents
  • 2.10.02 Declaration and/or Certification of Conformity

Chapter 3:

Rearrangements and New Content:

• • Section 3.05 – Other Studies have been reorganized to combine multiple documents into a single study. For instance:
  • 3.05.05.02 now encompasses the Risk Management File instead of just the Hazard Analysis. The Hazard Analysis is now part of the Risk Management File.

New headings introduced include:

• • Unresolved Software Anomalies
  • Interoperability

Chapter 4:

Additional Headings:

• • Real World Data
  • PMS Data

Chapter 6:

• • Chapter 6B Removed – All information previously under Chapter 6B has been consolidated into Chapter 6.

These updates ensure the document aligns with current standards and practices, providing clearer guidance and comprehensive coverage of essential areas. You can read the entire document here.

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