IMDRF Announces IVD MA ToC Updates

The In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) has been updated from 2019 to 25 June 2024 by the International Medical Device Regulators Forum (IMDRF).

Changes by Section Within IVD MA ToC:

Definitions: there are additions here to include regional content that wasn’t referred to in edition 3.

Full Report:  clarification is given that in some jurisdictions, full reports are always required as evidence which doesn’t mean as a manufacturer, you can’t create summaries to aid understanding inclusion or not of required documents. Regional content is now added to the document so that this content is covered in subchapters, while there is also inclusion of a not that some jurisdictions have Classification Matrices which may have further requirements in terms of content.

Information is also now included regarding electronic submissions with the FDA as this a new requirement (510(k) and PMS’s). There is an addition of a paragraph (page 7) specifying that for EU manufacturers of IVD’s reference to the requirements of the technical documentation as per Annex II and III of the IVDR, along with reference to MDCG guidance documents.

Chapter 2 additions – removed from Chapter 3 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:

• • Section 3.06  – Other Studies is now rearranged in terms of combining documents in one study – for example:
  • 3.06.02.02 is now covering the Risk Management File instead of just the Hazard Analysis. The Hazard Analysis is now included in the Risk Management File.
  • And includes new headings such as ‘ Unresolved Software Anomalies’ and ‘Interoperative’.

Chapter 4:

• • Extra headings such as ‘Real World data’ and ‘PMS data’ are now included.
  • Chapter 6B has been removed and all information is under Chapter 6 now.

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If you would like to discuss or need help understanding the updated IVD MA ToC, contact us so we can assist you. 

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