SaMD - Placing on the Market before DoA

[RA_QA_Expert]

Hi all,

based on MDR transitional period, class I MD placed on the market according to MDD before DoA (26.5.21) can be make available on the market (distributed) until May 2025. And some manufacturers take strategy to produce devices on stock (of distributors).

What about Software as Medical Device?

SaMD cannot be produced on stock physically, so if last version of SaMD is released in compliance with MDD and legally placed on the market before DoA, can manufacturer or distributor sells copies of this SW until 2025? Or?

Thank you for you thoughs

 

[yodon]

That's an interesting question. I'll say up front I don't know the answer. I suppose since there haven't been any other responses, there may not be clear direction here yet.

My guess is that if you ask your NB, they may say you absolutely have to get clearance under the MDR ASAP! May be a case where you don't say anything and see if they react. You could always argue if they push back that you're not rebuilding the binaries!

That argument falls flat, though, if you need to make changes.

Have you done a gap analysis to the MDR yet? Doing that, having a plan in place, and starting to close any gaps would certainly put you in a better position either way.

Keep us posted. I'm sure that sharing anything you learn would be appreciated here.

 

[Raisin picker]

I'd say you can distribute it until May 2024. I would argue that you are "manufacturing" a new copy of your device once it's downloaded from your repository.
This might be different when your distributor stocks the software in their own repository, and the final download does not require any interaction from your side. Try to provide enough licence keys in advance.

Of course, there is not one correct answer, it will depend on your NB and its certification agency, and also on your device and distribution structure. You should find your own answer and document the reasoning in your system (and here, as yodon mentioned).