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  • 1.  Technical Files - EU MDR and UK MDR 2002

    Posted 11-Sep-2023 08:47

    Hello,

    Seeking advice on how you are maintaining technical files for the same products in compliance with EU MDR and UK MDR 2002. Are you keeping two separate technical files or one technical file and including both GSPRs and Essential Requirements?



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    Charnelle Thomas RAC
    Vice President, Regulatory Affairs
    Canton GA
    United States
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  • 2.  RE: Technical Files - EU MDR and UK MDR 2002

    Posted 12-Sep-2023 04:28

    Hello Charnelle,

    Similar to a post made  today concerning what Technical Documentation looks like, first confirm with your Notified Body how they would accept ... and if moving to UKCA, your Approving Body the same question.  Generally, if you follow Annex II, with some "added" information (in reference to the other post) you should be able to only need one Technical Documentation file.  Within the Technical Documentation there would be sub-sections such as in classification which is an EU section and UK section (which often times would be the same anyway) or a sub-section for labelling for which one is EU and one is UK (if the labelling might be different).  As you can see if the information is the same, it would be easy enough to have just one file.  The General Safety and Performance Requirements (GSPR) and the Essential Requirements (ER) we recommend keeping as a separate document.  Then in the Technical Documentation a reference can be made to the GSPR for EU MDR and a reference made to the ER for UK MDR.  Same is true with other files such as labelling if there are two different labels used, then reference each part number per regulatory region.  It is quite a lot more work to maintain two files, but confirm first if you are using a Notified Body and potentially an Approving Body what their view is on using one/two files and review of a "combined" Technical Documentation file.



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: Technical Files - EU MDR and UK MDR 2002

    This message was posted by a user wishing to remain anonymous
    Posted 12-Sep-2023 09:05
    This message was posted by a user wishing to remain anonymous

    There is a prior post on this topic:

    https://connect.raps.org/discussion/ukca-and-mdr-submission-for-a-non-legacy-device


    Original Message


  • 4.  RE: Technical Files - EU MDR and UK MDR 2002

    Posted 12-Sep-2023 11:36
    Edited by Priyanka Potnis 12-Sep-2023 11:36

    Hi Charnelle, curious why you cant leverage your EU MDR certificate for commercializing in UK until 2030? Per MHRA transitional arrangements: "General medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030". Link: MHRA Transitional Arrangements

    You can download an infographic of the timelines for placement of CE marked medical devices on the Great Britain market under the Medical Devices (Amendment) (Great Britain) Regulations 2023



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    Priyanka Potnis
    San Francisco CA
    United States
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    Original Message


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