One Medical Device, two indications, two classes, one technical file?

jiligan

Involved In Discussions
If a manufacturer has one device that is sold with two different indications for use and one is a class I and the other a class IIa, can they have the same technical file with two different classifications with all documents in the tech file referencing both devices? The only document they would not share is the Annex I. Is this acceptable? Thanks for your help! :confused:
 

yodon

Leader
Super Moderator
Can't say for sure but it seems fraught with potential issues. How do you prevent the 'class I users' from using it in whatever way makes it Class IIa? How do you separate the risks / controls? How will you establish a UDI?
 

Sam Lazzara

Trusted Information Resource
It is not unacceptable if done right but ill-advised I think.

Do the devices have different REF numbers and IFUs? Or are both indications included in the same IFU?

Is the Class 1 device provided sterile or does it have a measuring function? If not, then Notified Body review/approval is not required and you may not want them "inadvertently" seeing the combined Tech File when they are reviewing the Class IIa device.
 
Last edited:

jiligan

Involved In Discussions
Both devices are identical, they just have two different indications for use, two different part numbers and each has their own IFU.

The class I is provided sterile as well as the class II.

Thank you for your comments :)
 

renenatasha

Involved In Discussions
:bigwave: I've similar question in regards to this: One MD, One Intended Use, Two Classifications, one TF?

I've a medical device which is sold as Class I non-sterile and Class I sterile but both have the same intended use. Is it possible to have one TF to cover both non-sterile and sterile version?

Share your thoughts please. Thanks :)
 
Top Bottom