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Harmonized structure for IVD regulatory submissions

Medical devices regulation

The document “IMDRF N13 (IVD ToC) RPS WG Ed 4 Final v4” by the International Medical Device Regulators Forum (IMDRF) provides a comprehensive and harmonized structure for in-vitro diagnostics (IVD) medical device regulatory submissions.


The document, produced by IMDRF, is freely reproducible and is meant to harmonize the structure of IVD regulatory submissions. It does not introduce new regulatory requirements but aims to minimize regional divergences.


The document stems from a proposal endorsed by IMDRF in 2012 to create a harmonized structure for regulated medical device submissions. It organizes submission content to accommodate a nested folder structure, facilitating easier navigation and ensuring comprehensive coverage for regulatory submissions.

Scope and Purpose

The document is designed for IVD regulatory submissions, including companion diagnostics, but excludes submissions for clinical trial approvals. It aims to provide guidance for industry to adapt to various products and minimize regional divergences.


Several terms are defined, including accessory, common content, full report, regional content, submission, and summary. Each definition clarifies the terminology used within the document to ensure uniform understanding.

Language Requirements

Submissions must adhere to regional language requirements. Translations must be verified for accuracy.

Hierarchical Presentation

The document outlines a hierarchical structure for submissions, specifying consistent numbering regardless of the requirement for each heading. The primary chapters include:

  • Regional Administrative
  • Submission Context
  • Analytical Performance and Other Evidence
  • Clinical Evidence
  • Labelling and Promotional Material
  • Quality Management System

Detailed Chapters

Each chapter contains specific headings and subheadings, detailing the required content for regulatory submissions. Key sections include:

Chapter 1 – Regional Administrative

Includes cover letters, submission table of contents, list of terms/acronyms, application forms, device listings, quality management system certificates, and other regional administrative information.

Chapter 2 – Submission Context

Covers the general summary of the submission, device description, intended use, global market history, risk management, standards, and other contextual information.

Chapter 3 – Analytical Performance and Other Evidence

Details requirements for analytical performance studies, stability studies, accuracy and precision data, validation of assay cut-offs, software and firmware information, and other evidence supporting the IVD device.

Chapter 4 – Clinical Evidence

Includes summaries of clinical evidence, clinical study reports, literature reviews, informed consent information, and real-world data.

Chapter 5 – Labelling and Promotional Material

Describes requirements for product/package labels, instructions for use, patient labelling, technical manuals, and promotional materials.

Chapter 6 – Quality Management System

Outlines quality management system documentation, including product descriptive information, manufacturing information, required forms, quality system verification documents, and other related information.


Provides a comprehensive list of acronyms used throughout the document to ensure clarity and understanding.

Document Revision History

Includes a section to track revisions made to the document over time.

Overall, this document serves as a detailed guideline for preparing IVD regulatory submissions, ensuring consistency, transparency, and harmonization across different regulatory jurisdictions.

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