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How is the service life for class I reusable medical devices described in MDR?

#1
I need to find out how the service life is described in the MDR for class I reuasable devices. Where does it stand in the MDR and do I need to display the service life in years or in maximum cycles of use?
Thank you for your support and informations in advance. I highly appreciate it.
 
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shimonv

Trusted Information Resource
#2
NDR, Annex 1, section 6:
  1. The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer's instructions.
 

shimonv

Trusted Information Resource
#4
The information about service life is the usually found in the User Manual. If you put maximum cycles the customer should have a means to keep track of it...
 

Raisin picker

Involved In Discussions
#5
Estimating 1 reprocessing cycle (as specified in document XYZ) per day, 6 days per week, 52 weeks per year, the lifetime is 6 years.

Something like that might be a possibility to describe the lifetime. Of course, the numbers should roughly reflect the typical usage of your device (several times per day, monthly, ...). The example above would add up to a bit less than 2000 cycles.
 
#6
We would state the service life of course in the IFU. If we put it in maximum number of reprocessing cycles we would add a sentence that the end user is obliged to record the reprocessing cycles by LOT number and ensure not to use it more thatn the indicated max. number of reprocessing cycles. Would that be MDR compliant?
 

planB

Trusted Information Resource
#7
Sonnenblume,

with stating a service life (and instructions what the user shall do with device once the service life is reached) you have fulfilled your obligations. It is up the user to establish a system meeting your instructions regarding the defined end of service life.

HTH,
 

Rincewind

Involved In Discussions
#8
I just want to add that, from my experience, most NB do not accept blank statements like "Life time is 6 years". They expect also data to support this claim, meaning you have to include test reports which help your statement which can be getting expensive really fast if you have to contract a laboratory to reprocess your device 2000 times.

So another method might be, depending on the complexity of your device to not define a hard number but define something like "signs of wear" but this also needs to be supported by test data.
 
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