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  • 1.  CE Checklist - Class IIa Medical Device under MDD

    This message was posted by a user wishing to remain anonymous
    Posted 24-Mar-2019 21:56
    This message was posted by a user wishing to remain anonymous

    Hi All,

    I am looking for a good CE requirements checklist/link for a Class IIa (non-sterile) medical device under the MDD.

    I am in the process of building the Technical File.  I have the following:

    • Risk Analysis 
    • Clinical Data according to the Med Dev
    • EC and UK Rep
    • SDS, labeing, translations and related
    • Agreements with distributors
    • All design and manufacturing info for the product family
    If anyone can share their experience/opinion, it would be greatly appreciated.

    Thanks


  • 2.  RE: CE Checklist - Class IIa Medical Device under MDD

    Posted 25-Mar-2019 02:50
    You can utilise the STED format defined in the original GHTF (now IMDRF) document, this is a decent structure.  In addition, the more recent RPS table of contents also works quite well for a structured methodology for technical documentation.  Just keep in mind that the STED format and RPS structure are international harmonised structure that is intended to be used in many different countries.  We have developed a technical documentation structure that incorporates STED, RPS, content of MDR Annex II, and experience with Notified Body reviews.  This means reviewing the MDD for additional information.  Recommend also discussing with you selected Notified Body if they have any structure or expectation for technical documentation.  Your list is a good start, but there are many items that may be missing.  Also note, that MDD will not really the way to go in the next few months and should look at Annex II of the MDR for technical documentation content and Annex III for the technical documentation related to post market surveillance.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: CE Checklist - Class IIa Medical Device under MDD

    Posted 25-Mar-2019 09:03
    Hi,

    I am providing a very basic checklist template on my website for Annexes I and II of MDR.
    You can find those here:
    MDR STED Checkliste für Ihre Technische Dokumentation | Medical Engineering

    And here is a direct link to the files, as my website is only in german language:
    https://med-engineering.de/wp-content/uploads/MDR_ER-EN.xlsx
    https://med-engineering.de/wp-content/uploads/MDR-STED_EN.xlsx

    Though this is not specifically for a IIa device and it is used for MDR, it should be a pretty good approach for any Tech.Doc.

    Still you might find checklists that suit a lot better.

    Hope it helps you anyhow.

    Thanks
    Sven



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    Sven Schaumann
    Dipl.-Ing.
    Potsdam
    Germany
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    Original Message


  • 4.  RE: CE Checklist - Class IIa Medical Device under MDD

    Posted 25-Mar-2019 11:02
    Add these to your list for consideration:

    NB-MED/2.5.1/Rec5, Technical Documentation
    GHTF/SG1/N011:2008, Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
    Also may want to consider adding the MDR elements too, its coming soon.



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    Michael Preto
    Avon Lake OH
    United States
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    Original Message


  • 5.  RE: CE Checklist - Class IIa Medical Device under MDD

    This message was posted by a user wishing to remain anonymous
    Posted 25-Mar-2019 20:16
    This message was posted by a user wishing to remain anonymous

    Don't forget to include the classification of your device, which rule etc and a justification for selecting that classification & rule.
    Also some NBs like to see a list of critical suppliers if applicable.
    Original Message


  • 6.  RE: CE Checklist - Class IIa Medical Device under MDD

    Posted 26-Mar-2019 06:21
    Hello,

    ….. did you consider the GHTF SG1 Guidance "Summary technical documentation STED". It can be found  on the IMDRF web side (International Medical Device Regulators Forum)

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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


  • 7.  RE: CE Checklist - Class IIa Medical Device under MDD

    Posted 27-Mar-2019 10:47
    I second the comment that you should reach out to your notified body.  They will typically have their own formatting and checklist that they prefer.  In addition to helping to answer your question, this will open up the lines of communication,  let your reviewer know that you are working to meet their requirements, and ensure that they know your submission is coming. Never under estimate the benefits of open lines of communication!

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    Jayme Calhoun
    Director, Regulatory Affairs
    Gainesville FL
    United States
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    Original Message


  • 8.  RE: CE Checklist - Class IIa Medical Device under MDD

    Posted 28-Mar-2019 23:30
    Agree with all of the posters on the utility of GHTF STED guidance.  

    But also of interest are the AHWP guidance on mapping to CSDT for Asia Pac countries at  and the very recent Dossier Table of Contents Pilot  by IMDRF 

    Arthur

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    Arthur Brandwood PhD FRAPS
    Founder and Principal Consultant
    Brandwood Biomedical
    Sydney, Australia
    Arthur@brandwoodbiomedical.com
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    Original Message


  • 9.  RE: CE Checklist - Class IIa Medical Device under MDD

    Posted 29-Mar-2019 10:47

    BSI published this guidance booklet for documentation submissions under the MDD in 2016 that many have found to be helpful.  Note the outline of "Technical Documentation Sections" in Appendix A.

    https://www.bsigroup.com/globalassets/meddev/localfiles/en-us/brochures/bsi-md-best-practice-documentation-submissions.pdf

    Best wishes, 
    Todd

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    Todd Moorman
    Assistant VP of Strategic Development
    Herndon VA
    United States
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    Original Message


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