#1
Hi all,

I'm from a US based company which markets a device in both the US and EU. It is FDA approved and has the CE mark. We are currently performing clinical testing (IDE) in the US and we also have several registry studies we intend to begin. Does ISO 14155:2011 apply to non-interventional registry studies? Would there be consequences if our registry studies did not comply with ISO 14155:2011, which I know has been harmonized with the MDD?

Any advice or knowledge would be much appreciated!

Thanks!
 
#3
I have the same question. ISO 14155 includes a reference to PMCF (MEDDEV 2.12-2 but the content is very specific to intervention pre-market studies - not observational post market studies/registries.

Would like to know if it's a requirement to follow ISO 14155 to the best of abilities (and potential perform a gap assessment where not applicable) for these types of studies when the standard is so heavily focused on pre-market conduct.

I've seen that this is being updated, but still not clear on whether or not this will be addressed in the update. Thanks!
 

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