Advisory Notice

[M_O_H]

Hi all,

I have a question please and would appreciate any help or advice. We are a medical device manufacturer and have identified a new risk, the risk might be related to adverse event however no death or injury happened or expected to happed if reoccurred, to reduce the risk we have updated the IFU and will notify to all customers. My question is do we need to notify regulatory authorities and provide updated IFU?

Thank you in advance.

 

[yodon]

These 2 statements seem contradictory "the risk might be related to adverse event" and "however no ... injury happened or expected to happened" If related to an adverse event, by definition that seems to say that injury could result if it occurred.

Also, reducing the risk based on an IFU update only (labeling) is likely unacceptable in the EU.

I think this would probably fall into the 'notify your NB' category but you may want to seek out expert opinion (i.e., paid regulatory consultant).