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  • 1.  EU MDR: ISO 13485 or ISO 9001?

    Posted 01-Oct-2021 10:45
    Good morning everyone, 

    I would like to have some insights on the following topic. Does a supplier of a medical device accessory (a bag to carry the accessory around) need to be ISO 13485 certified or is it ISO 9001 certification sufficient according to EU MDR? 

    Thank you very much, 

    regards

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    Martina Danesi
    Regulatory Affairs Intern
    RA-SCR Benelux
    Philips Medical Systems Nederland B.V.
    martina.danesi@philips.com
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  • 2.  RE: EU MDR: ISO 13485 or ISO 9001?

    Posted 01-Oct-2021 11:07
    Accessories are handled by the EU MDR as devices in their own right.  (EN) ISO 13485 is generally considered to be the state of the art regarding medical device quality management systems.  The EU MDR calls for proper consideration of state of the art.  However, one could probably make a strong case for the suitability of ISO 9001 regarding a low-risk accessory.

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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


  • 3.  RE: EU MDR: ISO 13485 or ISO 9001?

    Posted 02-Oct-2021 08:00
    Don't forget that 'Accessory' is a defined term in the MDR, Martina.

    Just because you call a particular product an accessory to your medical device doesn't make it an accessory under the MDR, so be careful to apply the criteria defined in MDR Article 2(2) to distinguish between an accessory that must be treated as if it were a device for compliance purposes, or a non-device product that may be associated with the device.

    For example, your carry bag, to be considered an accessory as defined in the MDR, needs to "specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)". If it doesn't do this, then it is neither a device nor an accessory, and is thus not subject to the MDR.

    Turning to your question of whether ISO 13485 or ISO 9001 would be most appropriate for such a product, this of course depends on whether you decide it is a device accessory, and thus must be MDR-compliant, or whether it is a non-device product.

    If it is an accessory, then you should apply the appropriate QMS requirements as required by its MDR classification. At your choice, this may or may not include certification to any specific ISO standard, but instead you will need to have either the appropriate notified body QMS certificate in place, or if Class I, self-certify against the requirements of MDR Article 10(9).

    If it is a non-device product, then it is your choice whether or not you decide to apply any specific QMS standard to its design and manufacture.

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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Ltd
    UK Responsible Person services
    Christchurch, UK
    +44 1425 489208
    rgray@donawa.com
    www.donawa.com
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    Original Message


  • 4.  RE: EU MDR: ISO 13485 or ISO 9001?

    Posted 02-Oct-2021 12:06

    Following the EU-MDR a medical device supplier or an accessory supplier does not need a certified QMS. This is also true of the supplier management requirements of both QSR and ISO 13485:2016.

    The EU-MDR Art. 2(2) defines "accessory for a medical device", so be sure the product meets the definition.

    However, some regulatory regions regulate an accessory as a medical device. In these cases, be sure the supplier meets the regulatory requirements which usually includes a QMS.



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


  • 5.  RE: EU MDR: ISO 13485 or ISO 9001?

    Posted 02-Oct-2021 12:42
    Hello Martina,

    in addition to the already made comments; I would carefully assess the functionality of the carry bag, and apply the Risk-Management System (in terms of production / supply chain related risks) to determine the acceptability of a supplier under ISO 9001. 

    PS The assessment might be similar a card box to pack the device which is typically sourced from ISO 9001 certified suppliers.

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    Uwe Zeller | Regulatory Affairs / Risk Management Consultant
    Biberach an der Riß, Germany
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    Original Message


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