Automated Platform (IVD) Classification/Registration (New to RA)

[fondantcookie]

Hi.

I am new to the forum (first post) and actually relatively new to RA; only recently starting work as an RA specialist for a medical devices/IVD manufacturer (following a background in R&D).

This may sound like a simple question but I'm really struggling to find an answer so am hoping someone can assist.

Our company manufactures a number of diagnostic IVDs (infectious diseases) and also a number of automated platforms upon which to run the IVDs.

I understand the classifications of IVDs however I am struggling to understand:
a) how is an automated platform classified? i.e. classification status (if any), and
b) are these CE marked and registered with the MHRA (for example) in the same way that IVDs are?

Thank you in advance for any help and support you provide.

Cheers

 

[Ronen E]

Re: HELP !! Automated Platform (IVD) Classification/Registration (New to RA)

Hello and welcome to the Cove!

I'm no expert on IVD "automated platforms" but I would just read the IVDD scope statements with those platforms in mind and see whether it sticks.

 

[Vitalix]

Hi.

I am new to the forum (first post) and actually relatively new to RA; only recently starting work as an RA specialist for a medical devices/IVD manufacturer (following a background in R&D).

This may sound like a simple question but I'm really struggling to find an answer so am hoping someone can assist.

Our company manufactures a number of diagnostic IVDs (infectious diseases) and also a number of automated platforms upon which to run the IVDs.

I understand the classifications of IVDs however I am struggling to understand:
a) how is an automated platform classified? i.e. classification status (if any), and
b) are these CE marked and registered with the MHRA (for example) in the same way that IVDs are?

Thank you in advance for any help and support you provide.

Cheers

Great question! I was just having the same one today, because we are going to have similar issue very soon: run several tests on one platform.

I guess, the IVDD is quite clear about it:

(c) `accessory' means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.

So for me it seems like accessory is the right term. And it's not IVD; but it needs to be included in the TF, to the best of my understanding, and to be assessed together with the IVD for safety and effectiveness (essential requirements), so to say including risk management and usability of the test + platform.

Please, fellow experts, correct me if I'm wrong about accessory place in the IVD world.

 

[fondantcookie]

Thanks for the hep I really appreciate it