3.2Sample general process for building a ToC-based submission
This section describes one example of how the pilot documents could be used to manually assemble an IMDRF ToC pilot submission. It is important to note that this is intended to provide further context to the pilot documents. Other approaches may be acceptable, including using a submission builder to generate a submission meeting the requirements defined in the pilot documents.
Step 1: Download2 the required IMDRF Standard ToC Folder Structure for the applicable ToC structure (e.g. IVD or nIVD)
Step 3: Consult the regional classification matrix of interest to establish which folders can be deleted from the comprehensive structure based on the submission type – see Section 4.1 below for further guidance.
The IMDRF TOC Pilot will rely on technical guidelines to provide consistency across the regions. The following sections include basic guidelines for submitting a TOC based submission.
The IMDRF documents, In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) and Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC) define the content for each folder. The folder structure is to be built as prescribed by IMDRF. Refer to the IMDRF Standard ToC Folder Structure file, which is a physical folder structure template provided by IMDRF to help facilitate the preparation of applications in the required ToC format.
Regional Classification Matrices describe which elements of the ToC are required for each regulatory submission within scope. There are factors influencing the inclusion/exclusion of submission contents, these considerations are detailed below.
Each folder within the submission can be established as either Required or Not Required for the particular submission. This can be explicitly defined by the classification matrix (e.g. Required or Not Required classification) or through interpretation of the classification (e.g. through assessment of conditions4 for those that are classified as Conditionally Required or a decision by the applicant for those that are classified as Optional). With this in mind, Figure below depicts many of the classifications that can result in a folder being Required or Not Required within the submission.
Any folder that is established as Required should not be deleted.
Any folder that is established as Not Required should be deleted to ensure the submission content package does not contain empty folders. If any parent folder contains no content, then that parent folder should also be deleted.
It should be noted that some regions may require a statement describing why a section is not provided (e.g., FDA sections located in Chapter 3 of the ToC).
Determined through interpretation of the condition4
Determined by decision by Applicant
Required (Keep and populate folder)
Not Required (Delete folder)
Required for ToC Implementation
Conditionally Required for ToC Implementation
Optional, but recommended
Figure - Those classifications defined in the classification matrix (rectangles) that can lead to content being Required or Not Required in for a particular submission (ovals).
4.2Folder Naming Convention
The folders in the provided templates will be numbered and named per the ToC requirements, with the exception of the custom headings which are to be numbered and named as defined in the IMDRF ToC (e.g. typically [Study description, study identifier, date of initiation]). The final digit of the heading number should be revised as appropriate to ensure appropriate sequential presentation of the custom folders when more than one study is being included. For example, for the Physical and Mechanical Characterization heading, the first custom study folder should be “3.5.01.1[Study description, study identifier, date of initiation]” and the second custom study folder should be “3.5.01.2[Study description, study identifier, date of initiation]”. If there are more than 10 studies, the sequence numbering should use 2 digits (e.g. 3.5.01.01, 3.5.01.02 for the example above).
Custom folder names are to be limited to 50 characters (including the section number).
NOTE: Restrictions in file and folder names exist to ensure maximum allowable system filepath lengths are not exceeded.
4.3File Format, Size and Naming
Portable document format (PDF) files are the preferred file format although other formats such as Microsoft Office (.doc, .ppt, .xls) are also acceptable in some regions. Refer to regional pilot guidelines.
The applicant should create all PDF files directly from the source documents whenever feasible rather than creating them by scanning. PDF documents produced by scanning paper documents are far inferior to those produced directly from the source document, such as Word document, and, thus, should be avoided if at all possible. Scanned documents, particularly tables and graphs, are more difficult to read and do not allow the reviewers to copy and paste text.
For any scanned document, you should perform optical character recognition (OCR) so that the text is searchable. Check to see that the content has been correctly converted by: (1) highlighting an area of text and (2) searching for a word or phrase. If the word or phrase is not returned in the search, then the OCR did not recognize the text. We recognize that OCR may not be feasible in some cases for documents with figures and images.
Most file names are user defined, with a limitation of 50 characters (including extension and section number). File names should be meaningful and provide some indication of their content. When more than one file is presented in a folder, suffix number should be used to ensure the intended sequence of presentation is maintained.
File names that are prescribed are those that fall under custom or user defined folders, where the following file names should be used:
No individual file in the submission shall exceed 100 MB.
The entire submission should not exceed 4GB.
NOTE: Restrictions in file and folder naming exist to ensure maximum allowable system filepath lengths are not exceeded.
Files should not have any security settings, specifically:
4.5Bookmarking in PDF Files
It is also important that PDF files be properly structured, with a properly bookmarked internal table of contents. The following are recommended as good structuring practices:
There are no limitations on the number of files per heading within the submission, however, the following guidelines should be considered.
184.108.40.206-Comprehensive Device Description and Principle of Operation.pdf
Pages of the submission should be numbered in such a manner that information can be easily referenced by page number. Pagination should be applied to each document (i.e., the physical file).
1 The IMDRF Table of Content Working Group is composed of the regulatory authorities from the agencies represented by the IMDRF Management Committee.
2 See IMDRF Standard Folder Structure file
3 For a complete description of common and regional content requirements for each heading refer to:IMDRF In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC) ORIMDRF Non-In Vitro Diagnostic Device Market Authorization Table of Contents (nIVD MA ToC)
4 Conditions for Conditionally Required headings are outlined in the Classification Matrices
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