Rework requirements
Under what circumstances a medical device which has already been put into service can be returned by the user or patient to the manufacturer to be repaired or modified? Does this trigger any documentation or procedures to be in place? What are the risks?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
According to the ISO 13485, requirement 8.3.4 Rework, you have to prepare documented procedure where you will state in which circumstances the patient can return the devices that need to be repaired. Also, in this procedure you need to state what records are necessary for the acceptance of such a product, and how you will record it when the repair is done, what kind of test you will perform to check the performance of the device (that the performance and intended use is the same as the original device, before the repair).
In your risk analysis, you have to take into account what kind of risks are there with the repair, for example, risk of damaging the device, risk of changing the performance and intended use, risk of the safety of the product.
Understood - thank you. Would MDR have any impact on performing this king of rework?
No, MDR does not have any impact on the repair, as long you have control over the process.
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Apr 20, 2021