Requirements on how long you have to keep Spare Parts for Medical Device Repairs

[markvm68]

Is anyone aware of any requirements that state you must be able to service a medical devices for a set period of years after it has been sold. This question comes up every year at our company. I have always stated that there is no regulatory rule governing this and that the decision is a business decision based on how well we want to service our customers.

Am I wrong?

Thanks

Mark

 

[Marcelo]

Hello Mark and welcome to the Cove.

Some regulations require that spare parts be mantained, for example, for the lifetime of the medical device.

You can find more information regarding this matter on the links on "Similar Discussion Threads" below.

 

[Peter Selvey]

The key point here is to differentiate between health/safety issues and commercial issues.

There may be rare cases where provision of spare parts is important for safety, but in general it is just a commercial issue: maintenance and repair takes place well away from the clinical environment.

Many may assume that even so, healthcare agencies should be given protection because of the large potential impact: making a $100,000 machine useless after 2 years.

But regulations tend to take the view that for commercial matters, professionals should look after themselves. If you buy a $100,000 machine, put it in the contract that spare parts must be available for 5 years. Didn't put it in the contract? Bad luck.

In Europe, for example, the warrantee directive 1999/44/EC gives 2 years protection to consumers, but a consumer is defined as someone not involved in professional activities. Professionals are left to look after themselves.