Regulatory Open Forum

 View Only

  • 1.  Medical Device File, DMR and Tech File

    This message was posted by a user wishing to remain anonymous
    Posted 29-Nov-2021 15:22
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Simple one, but hoping for some advice. We are an IVD manufacturer, supply to Europe.

    I want to try and get clarification once and for all on the differences between the following:

    • ISO13485: Medical Device File
    • ISO13485: Design and Development Documents
    • IVDD and IVDR: Technical File (documentation)
    • Device Master Record
    • Design History File

    My understanding (and i know this differs to the FDA):

    Medical Device File is for intents and proposes is the Technical file. In other words, by having a tech file SOP and product tech files compliant to the IVDR, you meet the requirements of the Medical Device File in ISO13485. So the SOP will outline the STED (Annex II and III) but in addition the Tech file/medical Device file will also include all the design history documents (D&D plans, Design reviews etc)

    Within the Tech File/medical Device File you will have a Device master Record, used to capture the product 'recipe' 

    The Design History File is an FDA only requirement and all design and development documentation (as per ISO13485) is captured within the tech file/medical device file.

    Does anyone have any comments on this?

    Thanks


  • 2.  RE: Medical Device File, DMR and Tech File

    Posted 01-Dec-2021 06:15
      |   view attached
    Dear Friend,

    medical device file = ISO 13485 4.2.3
    design & development documents = ISO 7.3.1 and Design Control Guidance (fda.gov)
    IVDR (2017/746) Annex II-III.
    DMR/DHF dhf_dmr_dhr_greenlightguru.pdf

    I think based on these a comparative table needs to be compiled, that will guide you through the similarities and differences. This takes time, but brings you to a clear overview and understanding.

    regards

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------

    Attachment(s)

    pdf
    DHF vs DMR vs DHR.pdf   79 KB 1 version
    Original Message


  • 3.  RE: Medical Device File, DMR and Tech File

    Posted 01-Dec-2021 10:27

    None of these 'files" is the same as the other. Each has different information from the others.

    The easiest way to see this is to list the required content from each file and then identify any other file that has the exact content. You will see that there is some overlap, but each has different content. Foe example, the IVDR Annex II required content is much larger then the ISO 13485:2016 Medical Device File.

    The good news is that with a well-designed file structure you can create each document one and only time and then point to it for the required file content. This makes change control easier.



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 4.  RE: Medical Device File, DMR and Tech File

    Posted 02-Dec-2021 11:09
    Dan's perspective is spot on as I have found an effective "future proofing" method employed by many is to include all the various requirements in a tabbed or indexed file.

    Attempting to maintain separate files that can potentially house duplicate data is cumbersome at best and unsustainable at worst (Change control nightmare).

    ------------------------------
    Michael Chellson
    MSc, RAC
    ------------------------------

    Original Message


  • 5.  RE: Medical Device File, DMR and Tech File

    Posted 02-Dec-2021 11:20
    Dear Colleagues,

    the EN ISO 13485:2016/A11:2021 has been issued yesterday (December 01, 2021) . It includes tables pairing the sections of ISO 13485:2016 with the ones of the MDR and the IVDR for those who like or need these.

    regards

    ------------------------------
    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
    ------------------------------

    Original Message


  • 6.  RE: Medical Device File, DMR and Tech File

    Posted 03-Dec-2021 10:12
    Peter,  EN ISO 13485:2016 A11:2021 has been available at BSI since September (announced at Compliance Navigator)  with annexes ZA for MDR and ZB for IVDR as you have stated, but the British Standards version also contains an Annex NZ for compliance with UK regulations.

    Next week, EN ISO 14971:2019 A11:2021 will be available according to CEN, and will contain Annexes ZA for MDR and ZB for IVDR.  I will be presenting on the new Z annexes for 14971 for AAMI Education on December 15 The annexes show how standard meets or does not meet the GSPR (Chapter 1) and does not contain any information about the Technical Documentation requirements of the regulation and how the standard may apply.  Dan has often written about Gap Analysis and how to use that to meet the regulatory requirements.  That applies to finding how your system can assemble the documents required for whatever regulations you are attempting to meet.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal Consultant
    ------------------------------

    Original Message


  • 7.  RE: Medical Device File, DMR and Tech File

    Posted 03-Dec-2021 04:53
    Edited by Jesin SYNTHEE 03-Dec-2021 04:53
    Hello,

    In short,

    DMR=Medical Device File (Identical, Same document 2 different names).
    Technical File = Elements of DHF plus Clinical Evaluation.
    Your DHF is the parent and Technical File is a child. 

    It is oversimplified above but thats fairly accurate.


    ------------------------------
    Jesin SYNTHEE
    Senior QARA Auditor
    ------------------------------

    Original Message


  • 8.  RE: Medical Device File, DMR and Tech File

    Posted 03-Dec-2021 10:03

    The Device Master Record (DMR) and Medical Device File (MDF) are not identical. If they were, they would have exactly the same content. However, a side-by-side comparison shows the differences.

     

    The list below shows the content of each. I've aligned them in spite of the different names.

     

    Device specifications DMR – Specification for product MDF

    Production process specifications DMR – Specification of procedures for manufacturing MDF

    Quality assurance procedures and specifications DMR

    Packaging specifications DMR

    Labeling specifications DMR – Specifications for packaging MDF

    Installation procedures and methods DMR – Requirements for installation MDF

    Maintenance procedures and methods DMR – Procedures for servicing MDF

    General description of the medical device MDF

    Intended use/purpose MDF

    Labeling and IFU MDF

    Specifications for storage MDF

    Specifications for handling MDF

    Specifications for distribution MDF

    Procedures for measuring and monitoring MDF



    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


Related Content