MD Technical Documentation and SALES possibility

#1
Hi all!

I am a project manager in one very young medical startup company based in Europe. We are developing Minimally Invasive Spinal Stabilization system. ( under MDR )

At the moment we are in a situation where the opinions of our consultants regarding the technical file of the product do not coincide.
I am asking for your help in solving a very important strategic issue.

Situation.
We are developing a MIS pedicle screw system, which consists of rods, implants (pedicle screws) and an appropriate set of instruments for the fusion.
The instruments are specially developed for our screw system. But it is not excluded that some instruments can be used in the future systems – like Open type.
Our Implant risk class is IIb. Instruments are I class (usually).
But we are informed by a consultant – “If your instruments are designed to be used with your MIS pedicle screws, they must be included into the ONE Technical File, and evaluated as risk class IIb” Is it right?
I have seen a lot of DoC’s and never seen that instruments are same risk class as the implants.

Also, if we create one Technical File for our system ( implants and instruments), does it somehow impact a possibility to sell instruments separately? ( not like a stand-alone medical device but as medical device which is the part of our system.. )

Example Situation:
Hospital purchases a full tray set of instruments and some implants. After one year, they lose a Bone Screw Driver. They want to buy an additional screwdriver. Are we allowed to sell it separately? ( if we have only one technical file to the whole system)

That’s the place, where opinions do not coincide.

Opinion 1 – If we have 1 Technical File describing the whole system ( implants and instruments + instrument trays) We are able to sell our system only as a full set and we are not allowed to sell that screwdriver separately.

Opinion 2 - Opinion1 does ‘not make sense, because that means – we also are not allowed to sell implants separately…. And submission of the one technical file describing implants and the instruments is completely impractical.

Opinion 3 – If we create one technical file, where we describe that these instruments are designed only to be used with these implants and this is a one system ( sounds crazy, that mean that instruments are same risk class as implants) are we able to sell this instruments and implants and so on, as a system component?

We are not going to sell these instruments as Stand-Alone medical devices, because most of them are designed to be used only with our pedicle screw system.

My personal opinion -based on this, we should create a separate Technical File for pedicle screws system ( which probably is at least 4 pedicle screws + 4 set screws and 2 rods, which create stabilization) and a separate one for the all instruments and separate for trays? Describing in that Technical files, that these instruments are used as part of the “OUR” MIS pedicle screw stabilization system. Or, we should create a separate technical file for each instrument?

I would really appreciate some expertise opinion from the industry professionals, who knows how the things happens. Thanks!
 
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