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  • 1.  GSPR POINT 22

    Posted 30-Sep-2021 14:47
    Dear all,
    We are preforming an audit and i have an misunderstanding on one point in the GSPR:

    Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

    Does this section apply to the surgeon or also a patient for an implant?

    I've written No applicable because the user should be the surgeon but for the auditor this section is also application for the patient.

    Please could confirm , I need to understand.

    Thank you in advance for your response.

    Rgds,

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    Nadine Adia
    Quebec QC
    Canada
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  • 2.  RE: GSPR POINT 22

    Posted 30-Sep-2021 16:42

    You need to clearly distinguish between the patient and the user. The MDR doesn't define them but, in many places, clearly distinguishes between them. For example, it considers harms to patients, users, or other persons.

    The user is the person who operates, handles, etc. the device and applies it to the patient.

    The patient is the recipient of the action of the device.

    In many cases the patient and user are different persons. However, they could be the same person – consider a home use blood pressure machine.

    In the implant case, the user is the surgeon who implants the device into the patient. The surgeon is not a lay person, so Article 22 does not apply to this user.

    There could be cases when the patient needs to operate or control an implanted device, in which the patient is also a user. For most implants, the patient doesn't operate it.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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    Original Message


  • 3.  RE: GSPR POINT 22

    Posted 30-Sep-2021 16:56
    The EU MDR includes definitions of 'user' and 'lay person':

    'User' means any healthcare professional or lay person who uses a device [Article 2(37)].

    'Lay Person' means an individual who does not have formal education in a relevant field of healthcare or medical
    discipline.

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


  • 4.  RE: GSPR POINT 22

    Posted 30-Sep-2021 16:48

    Hi Nadine,

    Is your labeling / instructions for use (IFU) addressed to professionals only (e.g. surgeons) or is there also a part of your labeling / IFU addressed to the patient (lay person)?

    Implants are typically not intended for lay use and thus GSPR 22 is generally not applicable with implants but there may be some exceptions out there.

    Here's the official MDR definition (Article 2, Definition 38) of a lay person in case that's helpful to support your argument with the auditor:
    'lay person' means an individual who does not have formal education in a relevant field of healthcare or medical discipline



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    Maria Laitenberger, Eng., M.A.Sc., RAC
    Regulatory Affairs and Quality Assurance (RA & QA) Consultant
    New Zealand
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    Original Message


  • 5.  RE: GSPR POINT 22

    Posted 04-Oct-2021 09:40
    Thank you so much @Dan O'Leary, @Kevin Randall and @Maria Laitenberger for these helpful feedback and You are right , for an implant the user is the surgeon who is not a lay person seeing all definition.

    Rgds,

    ​​​

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
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    Original Message


  • 6.  RE: GSPR POINT 22

    Posted 04-Oct-2021 10:46
    Hello Nadine,

    From my experience with implants and IFU, there can be 2 (or even more) users, for example surgeon, patient (lay person), etc. Most of you identify only surgeon as an user, but is this right? In implant case general safety and post surgical success depends on both - surgeon and patient as implant "wearer / user". So they usually have at least 2 completely different IFUs - for surgeon describing and addressing surgical risks, warnings etc. and other for patient, describing postsurgical risks, care, warnings etc. And this patient oriented IFU would be the one addressing GSPR22.

    That's my experience and point of view. Others may have different experiences.

    Best wishes,
    Aistė

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    Aiste Simokaitiene
    Kaunas
    Lithuania
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    Original Message


  • 7.  RE: GSPR POINT 22

    Posted 04-Oct-2021 16:04
    Good point @Aiste Simokaitiene,

    But what we said during our audit is that our IFU is not address to the patient but to the surgeon who is our user.

    However for my understand, from what you said , does it means that as manufactured we should have 2 IFUs ; one for the surgeon and an other one for the patient and put it in the website as required by MDR?

    Thank you .

    Rgds,​

    ------------------------------
    Nadine Adia
    Quebec QC
    Canada
    ------------------------------

    Original Message


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