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  • 1.  Definition of "Performance Characteristics" under EU-MDR

    This message was posted by a user wishing to remain anonymous
    Posted 06-Sep-2018 13:24
    This message was posted by a user wishing to remain anonymous

    ​Hello RAPS members,

    I have a question regarding the definition of "Performance Characteristics" of the medical device. Under EU-MDR, Chapter III, 23.4 Instruction for Use: (e) the performance characteristics of the device.

    How do you define "Performance Characteristics" of a medical device?

    Thank you.


  • 2.  RE: Definition of "Performance Characteristics" under EU-MDR

    Posted 07-Sep-2018 02:12
    Hi
    From my point of view "performance characteristic" include set of documents:
    usability (usability report in line with standard) supported usage by end user
    clinical efficiency (CER)
    clinical safety (CER)
    technical characteristics
    internal and external testing supported performance characteristic (electrical safety, mechanical strength, biocompatibility for instance,..)

    ------------------------------
    Evangelos Tavandzis
    Praha
    Czech Republic
    ------------------------------

    Original Message


  • 3.  RE: Definition of "Performance Characteristics" under EU-MDR

    Posted 07-Sep-2018 04:22
    Performance characteristics would in simple terms be the "specifications" of the device.  When you think of performance characteristics this is listing all of the information that a user would need to understand the operation, functionality, and specifications of the device.

    As an example, for an electrical device like a portable x-ray:
    - Operating temperature and humidity - operating conditions
    - Battery output at certain current (if a battery)
    - Power output at a current (if connected to wall outlet source)
    - Exposure time of device (may be programmable)
    - Duty cycle (linked to program settings)
    - Maximum output power

    etc. etc.

    You would typically find this in the back of an Instructions for Use or User Manual in a section called Technical Specifications or Device Requirements, something like that.  This would also typically include, if an electrical device, the immunity information related to IEC 60601-1-2.  I used an electrical device as an example because that is most common, but each device performance characteristics or commonly referred to specifications shall be conveyed to the user so they have safety and performance information of the device - just a note that this relates back to the General Safety and Performance Requirements and the risk management.

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


  • 4.  RE: Definition of "Performance Characteristics" under EU-MDR

    Posted 07-Sep-2018 11:19
    If your design process include requirements compartmentalization, the performance characteristics would be any technical solution to the "performance requirements"define as design input.

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    Marcelo Antunes
    Regulatory Strategy Consultant
    São Paulo
    Brazil
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    Original Message


  • 5.  RE: Definition of "Performance Characteristics" under EU-MDR

    Posted 10-Sep-2018 03:53

    Hello all,

    The wording performance characteristics only come up 3 times in EU-MDR (and much more in the IVDR).

     

    First occurrence is in recital 18. If you dissect the wording in (18), I would consider the word characteristics to be used 3 times, meaning design characteristics, safety characteristics and performance characteristics.

     

    It is more specific than design, safety and performance, as these might be seen as specifications (must meet), characteristics (meet/reality), process (without guaranteed result), etc.

     

    We also see performance requirements (must meet), performance aspects (elements of performance), clinical performance and performance. We also see in Annex I.6/7 etc. the characteristics and performance of the device

     

    The other two uses of the specific wording are in art 71.4.b, and Annex I.23.4.e

     

    In IVDR it is more frequently used, including as header for the specific requirements in Annex I, so section B.

     

    Having looked at earlier drafts, and discussions around it, I do not see any reference to the specific wording being meaningful.

     

    So, until we get guidance to see this otherwise, I would be inclined to not focus specifically on the word characteristics….

     

    Hope this helps.

     

    Kind regards

     

    G



    ------------------------------
    Gert Bos FRAPS, PhD
    CTO, Executive Director & Partner at Qserve Group
    Baarn
    Netherlands
    Gert.bos@qservegroup.com
    ------------------------------

    Original Message


  • 6.  RE: Definition of "Performance Characteristics" under EU-MDR

    This message was posted by a user wishing to remain anonymous
    Posted 10-Sep-2018 11:47
    This message was posted by a user wishing to remain anonymous

    ​Thank you All for the responses. This was very helpful.
    Original Message


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