Technical Files submitted for assessment Format recommendation 720 - - PDF document

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Technical Files submitted for assessment Format recommendation

Assessment Technical File format recommendation

720 DM 0801-49a Rev.0 du 20/10/2017 Page 2 sur 7

Contents

1. Approach ......................................................................................................................................... 3 2. Technical file structure .................................................................................................................... 3 a. Composition ................................................................................................................................ 3 b. Coherence of terminology ........................................................................................................... 4 c. Hard copy and electronic file overall structure ........................................................................... 4 i. Initial, renewal or modification notification file ...................................................................... 4 ii. Additional information request file ......................................................................................... 4 d. Technical file content .................................................................................................................. 5 3. The paper (hard-copy) file ............................................................................................................... 5 a. Equipment used........................................................................................................................... 5 b. File organisation visual markers .................................................................................................. 5 c. Paper hard copy to the LNE/G-MED ............................................................................................ 6 4. Electronic file ................................................................................................................................... 6 a. PDF electronic files ...................................................................................................................... 6 b. Page numbering and markers ..................................................................................................... 6 c. Submission of the electronic mail to the LNE/G-MED ................................................................ 7

Assessment Technical File format recommendation

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• 1. Approach

Assessment of technical files requires a precise and complete analysis of documents which may contain a large number of pages, overall. As a result, the quality of the format of these files (print-out, dividers, physical files, plastic inserts, pdf with no search facility, etc) varies and impacts the internal assessment organisation. This recommendation is designed to provide an initial guide with regard to the format of the technical files submitted for assessment to us. As a result, it sets out the instructions for the preparation of the technical files, and for their format only. This approach is designed under the auspices of the new 2017 745 MDR legislation which sets out in part Annex II relating to technical documentation : « The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner […]. »

• 2. Technical file structure
• a. Composition

A technical assessment file must comprise a minimum of:

• A paper copy file or binder file,
• The identical copy in electronic format or an electronic file

These two files, for which the contents must be strictly identical, are both essential to the successful conformity assessment of the medical device. These files must be submitted to the LNE/G-MED once only and be fully complete. Any additional documents submitted during assessment (appendices, corrections or other) shall not be accepted and shall not be taken into consideration. The technical file has to be written in French or in English. The chosen language for the writing of technical file will be the one used for the writing of the assessment report by LNE/G-MED. At the same time, submission to the LNE/G-MED of the following addition information is strongly recommended:

• photos pertinent to the device, or its commercial packing, with identification of

the position

• f

the different labelling and delivery documents,

• a prototype or sample in the commercial packing (as designed for marketing),

insofar as possible, and clearly identified as such.

Assessment Technical File format recommendation

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b. Coherence of terminology Generally speaking the terminology used must be strictly coherent with the whole of the file. As a result, if the name of the device has been modified (or changed) during its design and that previous names appear in the document copies (for example), the historic must be clearly described in the technical file introduction. Any omission of such may result in elimination of documents as items of proof (for example). By the same token, description of the items referred to in the technical file, for example, raw materials, packaging, must be coherent with the description of the item in the proof document, if not, the information must be clearly explained in the technical file so that the assessor may use the document as proof. c. Hard copy and electronic file overall structure i. Initial, renewal or modification notification file Generally speaking, we would point out that the technical files must be designed in order to fit in with the framework of the LNE/G-MED report and specific reports. These LNE/G-MED documents differ depending on whether it is an initial assessment, renewal, subsequent to modification, or depending on the type of the medical devices (combined products, packaging, sterilisation, etc). In this respect, it is recommended as a pre-amble to the technical file, that the following are indicated as a reminder:

• The subject of the file transmitted and the scope of the assessment expected

(especially if the file covers several devices),

• An accompanying letter specifying, for each of the different points (LNE

documents « list of items to be supplied »), the answers and the links to the corresponding technical documentation or justification for non-application or the non-impact of the modification on the report point. ii. Additional information request file Following assessment of the file, there may be a certain number of questions raised and which may give rise to additional requests from the medical device manufacturer. In this case, the manufacturer is notified of the request for further information and is submitted the list of questions.

Assessment Technical File format recommendation

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In return, we recommend the answers are in the same order as the questions posed in the notification letter. The establishment of a letter specifying for each of the questions and the links with the corresponding technical documentation (or the justification for the non- application or non-impact of the modification) is waited. This correspondence is to be incorporated into the foreword to the response file.

• d. Technical file content

The technical file includes a contents covering the whole of the technical file. The contents items shall give the detail and specify, (non-exhaustive list):

• the document headings,
• the number (reference, revision, application date) and electronic file name,
• the chapter numbers,
• the appendix numbers,
• the specific page numbers,
• the contents of each appendix.
• 3. The paper (hard-copy) file
• a. Equipment used

The different documents comprising the hard copy file are spiral bound, with the cover protected by a transparent page and stiff card page at the end of the document. Naturally, recto-verso printing, a high quality print, colour diagrams, the incorporating of high-resolution documents (if scanning cannot be avoided), are what are expected by LNE/G-MED.

• b. File organisation visual markers

The use of exhaustive and detailed content markers is required (general and appendices). This goes hand in hand with a clear and precise identification of the different documents, chapters, paragraphs, appendices and pages. As a result, it is essential to give on each document opening page the title and number of the document involved to enable reference to the corresponding contents logic structure. Each of the interlinked documents shall be organised using visually marked and identifiable

• dividers. The different items referring back to the content pages must be clearly legible, even

when the document is closed.

Assessment Technical File format recommendation

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And also, each page shall have either in the page header, the page bottom, the relevant page numbers, paragraph, chapter and document. c. Paper hard copy to the LNE/G-MED One example of each technical file must be submitted to the LNE/G-MED. It must be submitted for the attention of your contact at the Planification Evaluation de Dossiers (File Assessment Planning) department. In order to improve identification of the hardcopy (paper) files received, we ask you to quote in the LNE/G-MED project number, in the accompanying correspondence, for example. This number is generally notified before sending the hard copy.

• 4. Electronic file
• a. PDF electronic files

An electronic file contains several electronic files. These files must be compatible with the PDF format (Portable Document Format). Active word search (indexable) within all PDF files must be possible for all of the documents. The file name must enable a rapid and clear link with the file content. However, for technical reasons, the file name is limited to 50 characters and must not contain special characters ( _ @ - [ ] , etc. are prohibited). We recommend incorporating diagrams and pictures with their original resolutions and colours. And also, using several small files is preferable to using a single and heavy file with lots of pages.

• b. Page numbering and markers

For dividers, the PDF format proposes the use of markers, (tree structure) in order to

• rganise the document and enable coherent browsing with this type of organisation. Use of

markers for all electronic file documents is essential. Naturally each marker must have a link to the electronic file content (or corresponding appendix). And also, each page must have either at the top or bottom, the page, the relevant paragraph, chapter and document numbers.

Assessment Technical File format recommendation

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c. Submission of the electronic mail to the LNE/G-MED One copy of each e-mail technical file must be transmitted to the LNE G-MED. It may be transmitted using different supports: CD-ROM, USB stick or download website (WeTransfer for instance). In order to improve electronic file identification, we would ask you to include the LNE/G- MED project number, in your accompanying correspondence, for example if submitting by CD-ROM or USB stick. The correspondence and e-mails with the links to set up downloading must be submitted to your contact at the File Assessment Planning department. Electronic file exchange sites are not all accessible to our teams. As a result, use of the DropBox site should be ruled out.