Should the Label for Serviced Medical Devices be Replaced?

[shimonv]

Hi Fellows,
A client of mine recently replaced a Notified Body and a question arose:
Should they replace the device label to show the new NB number whenever they receive a devices for service & repair?

It seems like a 'gray area' although it makes sense to do it, but the logistics effort is substantial.

Any thoughts?

Shimon

 

[BhupinderSinghPawa]

NBOG's guide on change of Notified Body
http://www.doks.nbog.eu/Doks/NBOG_BPG_2006_1.pdf

Key Takeaways -

The (previous NB) certificates are valid for the devices, which have already been produced.

The manufacturer will need to liaise closely with the new NB and the previous NB to agree to the extent that any old labeling (containing the old NB’s number) can be used. This applies as well to the use of the identification number in brochures and promotional materials.

The change in the labeling has to be fixed to a specific production or batch number and has to be documented.

 

[shimonv]

Thanks, this is useful. To be fare - this guidance document focuses on the transition period and not on what happens afterwards, but its fair to assume that no labeling changes are required for products manufactured under the supervision of the previous NB.

Shimon