Responsibilty for corrective works required by MDA

[Garry]

Hi All,

I'm sure most will have an opinion on this but is there any official guidance on where the responsibility lies to implement equipment modifications detailed in a medical device alert when the cause of the alert relates to equipment design?

Cheers

[Danny.Withers]

Evening Garry,

As far as I understand, if a manufacturer issues a Field Safety Notice, (usually in response to a Patient Safety Issue), then these are generally mandatory actions the manufacturer will take themselves directly or offer instruction/guidance on operators to action/follow. The MHRA will normally issue these FSN's on behalf of the manufacturer following an investigation by both parties.

A manufacturer may provide instruction/guidance on voluntary upgrades to hardware/software which generally improve performance or add features to a device, but these are generally not mandatory upon the manufacturer to implement. These will not be related to patient safety issues identified.

In conclusion, the manufacturer or MHRA will issue FSN's where the manufacturer is required to take corrective action. An 'alert' relating to equipment design will have been issued only when a patient safety issue has been identified. If it is just a product improvement, then no FSN will be generated.


Kind Regards,
Danny

[Garry]

Thanks Danny