How long must I provide service or spare parts for medical devices

A

AOIRA

Other than in the country of Turkey, is there any guidance or requirement for how long I, the manufacturer, am required to provide service or spare parts for the medical devices that I distribute domestically in the U.S. and internationally?

If no guidance or requirement, how about sharing with me how long you provide support?

Thanks!

David
 
B

brandomenon

Off the top of my head, I'm not certain what the regulatory requirements are. My previous experience is that our company always provided service and support for "the lifetime of the device."

As long as we were maintaining licenses for the device, we kept replacement parts available, and the service staff maintained training on how to perform maintenance on the device.

Once a device was discontinued (for a better replacement), there was a process of decomissioning the product line - discontinuing licenses where applicable, informing customers (about the benefits of upgrading :) ), and eventually clearing stock of the replacement parts.
 
somashekar

somashekar

Leader
Admin
brandomenon said:
Off the top of my head, I'm not certain what the regulatory requirements are. My previous experience is that our company always provided service and support for "the lifetime of the device."

As long as we were maintaining licenses for the device, we kept replacement parts available, and the service staff maintained training on how to perform maintenance on the device.

Once a device was discontinued (for a better replacement), there was a process of decomissioning the product line - discontinuing licenses where applicable, informing customers (about the benefits of upgrading :) ), and eventually clearing stock of the replacement parts.
Click to expand...
Life time of the medical device as stated in your design requirement. Brando has stated very logical process of supporting your device in field.
 
B

Burgmeister

In the EU, the requirement is Device Lifetime as stipulated in your Technical File. Our company uses a Device Lifetime of 8 years, so for 8 years after the final product rolls off the production line we will offer support for it.
 
A

alex.Kennedy

It is documented in CFR's, and the last time I referenced it, it was given as;
The lifetime of the product plus one year.

Alex Kennedy
 
R

rickby

As far as I am aware it is defined as the "lifetime of the product" which should be defined by your design team in the Technical File. For example, if it is an electronic device then your designers should estimate how long the product is expected to last. However, beware of obsolete parts which might be critical and make sure that you have some spares kept by in order to provide service.
 
A

AOIRA

How cool is it that not only do I get five great responses, but each response is from someone in a different country! Thanks to all of you, Marc too, for helping me out.

Best regards,

David
:thanx:
 
C

Chris Ford

chudsy said:
Hi,
Is this documented anywhere in the MDD ??
Regards
Click to expand...

Yes. Annex I specifically talks about maintaining the essential performance characteristics, clinical conditions and safety of the patient for the lifetime of the device. It ties to the outputs of risk analysis.
 
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