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ISO 13485 Servicing vs FDA refurbishment of medical devices

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Guest user Created:   Jun 19, 2020 Last commented:   Nov 08, 2023

ISO 13485 Servicing vs FDA refurbishment of medical devices

Is there a difference between ISO 13485 definition of servicing and FDA definition of refurbishment of medical devices?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jun 23, 2020

Yes, there is a difference. In ISO 13485:2016, requirement 7.5.4 Servicing activities are repair and/or preventative or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications.

According to Section 710(c) of FDARA, FDA differentiates the following terms: refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device. Those definitions you can find in the following document: FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices https://www.fda.gov/media/113431/download

More information on service provision you can find in the following article:

How record for servicing activities looks like in ISO 13485:2016 Documentation toolkit, you can find in the following link:

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Adriaan Intveld Nov 07, 2023

Hi Kristina, in ISO 13485, clause 7.5.4 Servicing activities, twice the word 'supplier' is mentioned. What kind of company is considered a supplier here? 

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Kristina Zvonar Brkić Nov 08, 2023

This means that service activities can be provided by your supplier, and service activities can be outsourced to some other company. Then, of course, with this outsourcing, the company must be managed as described in 4.1.5.

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Nov 08, 2023

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