Hello Anon,
I am not sure following the question or thought process because updating the Instructions for Use (IFU) can depend on many different factors. There is no requirement to update an IFU regularly, but indeed there may be a need to keep it up to date. Revising the IFU regarding Notified Body in the EU depends on whether the change would be "significant" or not. There is not a requirement for an annual update or notification - again this really depends on any changes which are made to the IFU.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 28-May-2022 11:42
From: Anonymous Member
Subject: IFU updates & translations
This message was posted by a user wishing to remain anonymous
Hello,
Can someone share their experience with how frequently an IVD mfg. needs to inform the Notified Body of IFU transition updates. Knowing there is a requirement to keep the IFU up to date, what's this timeline look like given the costs associated with translations and the fact that some updates are minor in nature and of minimal risk. IMO it seems logical to periodically update and translate the IFU at rate based on risk/user environment and inform the NB annually of such updates, unless they are of significance or to mitigate product problems, etc.
Curious what others think or if there is a practice or guidance to refer. Thanks in advance to those of you that respond.