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Spare Parts for Medical Devices


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  Post Number #1  
Old 11th February 2009, 09:21 AM
Deacon

 
 
Total Posts: 1
Please Help! Spare Parts for Medical Devices

I am looking for any laws, regulations or documented requirements concerning how long a manufacturer has to provide spare parts for medical equipment. Specifically PC Board Assemblies.
Thanks,

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  Post Number #2  
Old 11th February 2009, 09:51 AM
DannyK

 
 
Total Posts: 653
Re: Spare Parts for Medical Devices

I do not know of any laws, regulations or documented requirements regarding spare parts.
It would be advisable to inform your customers that you will not be supporting the medical device after a certain date.
The spare parts business is usually a lucrative area and there are some electronic manufacturing companies that support spares for certain OEM's, with the approval of the OEM.
Thanks to DannyK for your informative Post and/or Attachment!
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  Post Number #3  
Old 11th February 2009, 10:12 AM
MIREGMGR

 
 
Total Posts: 3,683
Re: Spare Parts for Medical Devices

In jurisdictions where the Medical Device Directive applies, Annex I Section I Part 4 ("lifetime of the device") might be interpreted to require that, if a lifetime has been declared or implied for the product and the nature of the product is user-understood to be such that it is repairable rather than disposable within that nominal lifetime, spare parts must be available throughout that lifetime for any aspect of the device that affects either safety or effectiveness.

For a device without a declared lifetime and for which repairability is intended when the product is relatively new, it may be implied that spare parts must be available as long as someone continues to have the device in service.
Thanks to MIREGMGR for your informative Post and/or Attachment!
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