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  • 1.  Technical File Formatting

    Posted 08-Nov-2017 17:17
    Hello fellow colleagues,

    I am working on our Technical File for CE Mark.  I was wondering how many people follow the guidance document to have the Part A and Part B formatting.  This seems redundant to me compared to just having one main file that includes everything.  Also, I was curious how many put everything into a single document versus how many have a separate file for each of the sections/annexes?  Looking for some best practices as I try to navigate the technical file.  We already have our 510(k) and a previous de novo, but am not sure how to move the formatting over to the Technical File for CE Mark.  Thanks in advance for your suggestions and expertise.

    Lisa

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    Lisa Claude RAC
    San Francisco CA
    United States
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  • 2.  RE: Technical File Formatting

    Posted 08-Nov-2017 17:32

    I infer that you intend to get the CE Mark following the MDD Annex II. Because you are making a technical file, not a design dossier, you have a Class IIa or a Class IIb device.

     

    Under the MDD, since you are a US company, you must have an authorized representative in the EU. The authorized representative must have a portion of the technical file. The guidance document, I don't recall the number, suggests dividing the file into two parts. You as the manufacturer hold both Part A and Part B, while your authorized representative holds only Part A.

     

    With the EU-MDR, the requirement changes, so the authorized representative has the complete technical file. I recommend that you provide the full technical file to the authorized representative under the MDD. In addition, establish a procedure to ensure you communicate changes to the authorized representative. That way, as you migrate the technical file from the MDD to the MDR, you will comply with the MDR requirement.



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    Dan O'Leary
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: Technical File Formatting

    Posted 08-Nov-2017 22:56
    ​The only thing that is really important is that you have all the necessary documentation and that it is readily available for auditing as needed.

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    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


  • 4.  RE: Technical File Formatting

    Posted 09-Nov-2017 07:08
    Even before the MDR became a factor, I found the Part A Part B rather ridiculous and superfluous, since in my case the file is essentially an index to existing DHR and DMR files with the exception of the DoC and EC Certificates.  With the MDR and the requirement that the entire file reside with the EU Rep, the definition of the parts becomes totally irrelevant.

    James




    Original Message


  • 5.  RE: Technical File Formatting

    Posted 09-Nov-2017 12:26
    Hi Lisa,

    I agree with the previous commenters, especially that the most important thing is meeting all the necessary requirements – each company can find the format that works for them. 

    Regarding your question about one file vs. multiple files, I thought I'd share what my company has moved to over the last few years, as it works quite well for us. We have made our class III design dossier into a modular document, with a separate section for each main topic (preclinical, clinical, sterilization, etc.). Each module can be reviewed and approved separately, and includes all the attachments relevant to that section. We also have a TOC document that lists all the modules and their current revs, to tie it all together. 

    The benefit to this is that when making a change, we can update only the specific module(s) to which the change applies; this is much more manageable than an entire dossier update. 

    Jennifer

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    Jennifer Cabralda, RAC (US, CAN)
    Richmond, BC, Canada
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    Original Message


  • 6.  RE: Technical File Formatting

    Posted 09-Nov-2017 18:59

    Thank you to everyone for your advice.  I greatly appreciate it.  It seems like I should be embracing the fact that there is no requirements and set it up in the way that works best for us ensuring that all the content has been covered.  I really appreciate all the great insight.

    Lisa



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    Lisa Claude RAC
    San Francisco CA
    United States
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    Original Message


  • 7.  RE: Technical File Formatting

    Posted 10-Nov-2017 07:28
    ​Additional worthwhile reading may be found in a previous Forum thread :

     

    Subject : Use of the term "Technical File"

     

    https://connect.raps.org/communities/community-home/digestviewer/viewthread?GroupId=97&MessageKey=27d8fabf-6d7a-40c8-a907-d4c8a9fd754a&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer

     

    With the practical implementation of the MDR/IVDR getting closer by the day, you should have a look at their Annexes II (Technical Documentation) and Annexes III (Technical Documentation on Post-Market Surveillance). My recommendation would be to structure your files along the lines of these Annexes.

     

    With kindest regards,



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    Ary Saaman
    Director, Regulatory Affairs
    Debiotech S.A.
    Lausanne
    Switzerland
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    Original Message


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