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I use a FDA and CE registered sub-contract manufacturer for a FDA and CE registered Class 2a hand-held device., which my company sells around the world (in small numbers).
We have implemented the UDI requirements. All fine.
The issue comes when the manufacturer does service/repair on the products. (product life is often >10 years) and products come back for calibration and repair.
When older units come back for repair, the serial number label is often missing or unreadable from outside the unit. We also put a serial number inside the unit and we have records of every unit sale, we can identify these units for service.
The question is that the manufacturer is insisting that new UDI labels need to be prepared for these old units because “under FDA and CE guidance they have to ensure that service and repair units meet manufacturing standards”.
Its time consuming and expensive to do this.
My argument is that service and repair can be undertaken by any service organisation. If a hospital uses another repair organisation, there is no ability to replace or create UDI labels.
Everything that I can find relating to this says that service and repair organisations have to ensure that product meet manufacturer specifications, but not manufacturing standards.
My understanding is that as the marketer of the product I could engage any service organisation to service the product, providing records and kept and the operating specs are met at the completion of the service?
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Posted by Ann Angel
Asked on August 18, 2019 5:18 pm
First time in Europe!
The 10x Medical Device Conference
– 17 February 2020 in Central London
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