EBME Forums Forums Maintenance Technical Assistance European guidelines for warranty & spare parts

Dear all

I am looking for European guidelines/stamdards regarding manufacturer warranty periods and availability of spare parts from last manufacturing date for medical devices. In the past, manufacturers used to give out 1 year warranty and 10yrs availability of spare parts but nowadays varioous manufacturers give out longer warranty periods and less than 10yrs spare parts availability.
Thank you in advance
Melina

There are no set legal requirements for parts or warranty periods but most manufacturers follow accepted codes of practice as laid out in this document produced by COCIR.

That's a nice document, Mike. Albeit slanted from the point of view of manufacturers' service departments (I would say).

I would comment as well that it doesn't make too much fuss about what we like to call "electrical safety testing".


Yes.

Back to the good old PPQ* form - hopefully filled in way before any decision to purchase has been made**. In it the manufacturer declares for how long they will provide spare parts, if the date is too soon do not buy that product.
And as a caveat to this when spare parts unavailability is on the horizon start to plan the replacement. Yes you might be able to keep it going with "best effort" support but if this fails to keep the machine running it means you are then in an emergency replacement scenario where there is no real time for trials and a reasoned approach to the next purchase.
Even if you do not make the purchase immediately at least spend some time deciding what you want to buy when the time actually comes.
Robert

*Pre purchase questionnaire
** I know of one place where the standard practice was the supplies department calling the tech to sign the PPQ as they were placing the order - what happened if he found something that he did not like - such as a short support date - too late then.