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  • 1.  Servicing Previous Model Devices

    This message was posted by a user wishing to remain anonymous
    Posted 01-Aug-2022 13:39
    This message was posted by a user wishing to remain anonymous

    Hello,

    Can service and repairs be performed on a medical device model that was licensed, but the license has since been updated with newer model numbers?  What, if any, concerns should I be aware of related to servicing?

    Thank you.


  • 2.  RE: Servicing Previous Model Devices

    Posted 01-Aug-2022 15:25
    Medical device servicing can be a very complex subject.  I'll kick off the discussion by simply saying that if a device unit remains in use in the marketplace, and if servicing is a specified requirement, then the required servicing of that unit must continue to be provided in accordance with the specified requirements regardless of associated licensing or model numbering issues.  Failing to do so would be contrary to public health, and would generally be categorized as a nonconformity against, for example, ISO 13485 clause 7.5.4, FDA's 21 CFR 820.200, etc.

    It would also be good for us to know:  When you say "licensing", are we talking about premarket regulatory authorizations like a Canadian Medical Device License, like an FDA 510(k)-clearance, etc.?  Or are you instead referring to some type of business/corporate licensing agreement, or even to something else?  In any event, my first paragraph will still generally apply, though certain logistical adjustments might be needed during implementation.

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


  • 3.  RE: Servicing Previous Model Devices

    Posted 02-Aug-2022 02:55
    Hello Anon,

    Agree with Kevin that servicing and repair of medical device products can be a complicated subject and depending on type of device, versions of hardware, versions of software, spare parts, etc., configuration management is a crucial aspect to consider.  Also not sure what is meant by license such as a regulatory approval.  Making some assumptions here as you have a medical device Model 100 which is approved under License ABC which has been sold for a number of years.  The company then introduces Model 200 which is approved under License DEF and also sold for some time.  At the same time Model 200 is approved, Model 100 is stopped manufacturing and selling.  However, there are still 'X' number of Model 100 in the field which needs to be serviced and repaired.  Indeed it is the manufacturers responsibility to service and maintain Model 100 devices as long as they are in the market.  This is why a "end of life" programme is so important for durable medical devices which may be on the market for many numbers of years because it does not matter how long the products are used, it is still under the obligation of the manufacturer to service and repair these products.  So back to original statement, servicing and repairs of medical device products can be quite complicated when there are multiple versions and multiple approvals of products in the market.

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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


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