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  • 1.  EU MDR Tech File Bundling

    This message was posted by a user wishing to remain anonymous
    Posted 01-Mar-2021 19:07
    This message was posted by a user wishing to remain anonymous

    Hi All,

    Our device is currently marketed only in US. We are considering of launching it into EU. We are preparing the strategy to launch it and make ourselves ready for EU MDR. It looks like it will be Class IIa device but it has more than 7 accessories and kits. Can anyone please help me understand if we can bundle tech files to include all Class I accessories. Is it possible to have 1 tech file for multiple device under EU MDR like we bundle submissions for FDA?


  • 2.  RE: EU MDR Tech File Bundling

    Posted 02-Mar-2021 01:50
    Good morning

    One technical file covering several products is possible, you can even mix different classes (e.g. implants and their instruments). Whether or not it makes sense is a question of your strategy and how it was built up so far. Many of your DHF documents may anyway need to cover all products if they are used together (e.g. risk management, human factors, and clinical evaluation).  

    Class IIa (in fact all classes except class I non-sterile, without measuring function and not a reusable surgical instrument) products require the involvement of a Notified Body and please start looking for one at your earliest convenience - they currently are a precious good (shortage). "Pure" class I products need to be notified to the local competent autority of the country where your authorized representative resides.

    From a strategic perspective it makes sense to CE mark the smallest unit you intend to sell. This is important e.g. regarding kits: if you CE mark only the kit you will not be able to change the number and kind of products in said kit. On the other hand, if you CE mark every individual product, you have more flexibility.

    Please keep in mind that the date of application of the MDR (Medical Device Regulation (EU) 2017/745 is 26 May 2021.

    Cheers, Beat



    ------------------------------
    Beat U. Steffen
    Founder & CEO
    confinis ag
    Sursee
    Switzerland
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    Original Message


  • 3.  RE: EU MDR Tech File Bundling

    Posted 02-Mar-2021 04:48
    Hello Anon,

    There are a number of ways Technical Documentation can be structured which depends on type of device, type of accessories, intended use of device, and how these products may be sold or marketed.  Also depends on your Quality System structure as well on how you are establishing Product Family, the Tech Doc content, and how this aligns to your other documentation like Design History File or Medical Device File.  If your accessories are sold separately, it indeed might be better approach to have these in a separate Technical Documentation file.  Beat is really correct though want to look at having minimum number of Technical Documentation files - or what makes sense - because there will be a charge by the Notified Body for review of each file.  And also a very good point about making "kits" because may give more flexibility later on.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: EU MDR Tech File Bundling

    Posted 02-Mar-2021 07:03
    This may be a notified body specific conversation. I have seen differences on this point based on notified body. I have seen some accept bundling as long as they are part of a system or if the indicated use is similar and they can be grouped as a family. So it is likely worth having the conversation with the notified body. 




    Original Message


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