Regulatory Open Forum

 View Only

  • 1.  User Interface and Translations

    This message was posted by a user wishing to remain anonymous
    Posted 24-Jun-2020 12:10
    This message was posted by a user wishing to remain anonymous

    Hello, we have a class IIa device we're going be bringing to market in the EU. The instructions for use will be in member state languages. My question is, under the MDR, does the software of the device user interface have to be in multiple languages as well?  I don't see anything that says you must, but I'm curious if there is maybe an unwritten consensus within the industry I'm unaware of, or a portion of the MDR I am overlooking or not considering. If I am missing it, is there something someone could perhaps point me to that shows that requirement? Thank you.



  • 2.  RE: User Interface and Translations

    Posted 25-Jun-2020 05:01
    Hello,

    Indeed you will probably not find anything specific, however, many regulatory bodies and reviewers consider any user interface to be part of labelling.  Also more specifically if you review the GSPR, Annex I of EU MDR 2017/745, there are many locations were you could receive a nonconformity for not having the software user interface also in the member state language where the product is placed on the market.  As an example, GSPR 1, 2, 4, 5, 14, 22, 23.1 have many inferences about risk, use of device, lay-person use, etc.  Otherwise you will need to have a really good justification why the software user interface is only in one member state language or have some exemption provided.  This might be a bit difficult to go this route.  The products we developed, manufactured, and placed on the market with software user interface always had the ability to change language to local language option.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 3.  RE: User Interface and Translations

    Posted 26-Jun-2020 03:17
    HI ,

    I am with Richard on that. If you start addressing risks from human factors, there are a lot of hazards and hazardous situations coming from the interaction of the user with the interface. The language is one major parameter.
    It might not be a direct requirement, but you have to control those risks appropriately

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 4.  RE: User Interface and Translations

    Posted 21-Mar-2022 10:42
    I follow those statements if you are releasing a software towards lay persons and for instance home use
    If the software is only used by medical doctors, I believe we can estimate that they are sufficiently known with the English language, so that only translation of the basic IFU and related warnings translations should be sufficient

    ------------------------------
    Franky Dubois
    QA/RA Manager
    Gent
    Belgium
    ------------------------------

    Original Message


  • 5.  RE: User Interface and Translations

    Posted 22-Mar-2022 08:38
    Hi everyone

    You may assume what you want for HCP Users, but check country legislation.   In Spain, there was a Royal Decree that Spanish must be provided, even for HCPs; there is similar national legislation in other countries throughout EU/ETFA.


    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 6.  RE: User Interface and Translations

    This message was posted by a user wishing to remain anonymous
    Posted 21-Mar-2022 15:35
    This message was posted by a user wishing to remain anonymous

    Like everyone stated, there may not be specific guidance under MDR. But there's guidance under ISO 15223 and possibly 62304 and 80002 as well as ISO 13485. Risk management principles under ISO 14971 would suggest that the user interface should include options to switch languages to a more native and familiar one for the user. So ultimately you will be led back to the software design, in particular the user interface requirements. Knowing your audience and the many ways your software may end up in the hands of non-native speaking users will be important.
    Original Message


  • 7.  RE: User Interface and Translations

    Posted 22-Mar-2022 02:53
    Edited by Erik Vollebregt 22-Mar-2022 02:54
    I echo all the comments about risk and usability because you just cannot always assume that any professional user will always understand other languages.

    And then there is also legislation outside the MDR to take into account: for example France has workplace regulations that entitle employees to a French language working environment only. You will not have happy customers and won't be happy yourself either if your software does not accomodate workplace regulations and was supplied under a general 'compliance with all laws' clause.

    ------------------------------
    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
    ------------------------------

    Original Message


  • 8.  RE: User Interface and Translations

    Posted 22-Mar-2022 15:08
    The EU MDR requires that the information provided on the medical device software user interface (or any other aspects of the user interface) must be in the user's language.  That is principally governed by Article 11 stating that the label and instructions for use must be in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.  The EU MDR states that those particulars must be clearly comprehensible to the intended user or patient.  The premise for this is that the information provided on the user interface is generally considered to either be part of the "label" or the "instructions for use" (see the corresponding Article 2 definitions).

    A secondary EU MDR provision governing the need for comprehensible user interface information in the user's language is indirectly governed by Annex I.23.1(h) which offers the means of using approved symbols instead of native text to convey the information.

    Note also that EN 62366-1 as amended is generally recognized as the state of the art usability engineering standard for the EU MDR, and it defines that the labels and instructions for use are part of the user interface, thus further reinforcing the need for translated or symbolized user interface information.

    Accordingly, failure to have readily available translated user interface information or appropriate symbolization would not only represent a nonconformity against EU MDR Article 11, but also against the EU MDR's requirements for adequate usability.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 9.  RE: User Interface and Translations

    Posted 22-Mar-2022 20:58
    Hello,

    From my experience, you do need to have the screens on your UI translated into the language of the member state where you'll be marketing or commercially distributing your device because it's considered part of your labeling.

    ------------------------------
    Carol
    ------------------------------

    Original Message


Related Content