Technical File - Device Familly & Accessory

[ParisTommy]

Hello,

We manufacture sterile surgical invasive devices (class III).

We are developping a range of devices with different sizes.
Whilst these devices will all generally have the same intended use, there will be various contraindications depending on the different sizes (smaller devices will have access to a greater range of physiological locations, larger devices are more restricted).

The device will be connected to an accessory (specially designed control-box with the power source, an on/off switch and LEDs to indicate the operation of the device or a red alert LED in case of an error) the box will contain software* to manage the flow of the electrical current to the device.

The R&D team have asked me to advise how to structure the dossier

- can these all be bundled into the same CE Mark technical file?
- if they are in the same dossier, should we have a seperate Risk Management File, Usability file for the different sizes, the accessory-power control box and the embedded software*?

My thinking is :
The whole range (all the sizes) plus the power control box with the embedded software* can all be combined into a single CE mark submission file, with a single risk management file, usability file, clinical evaluation report etc,

Each update to the range e.g. adding another size, we can make a revision to the risk management file to address any particular issues with the new indication / contraindications.


I just don't want to make a fatal error at the begining of the design of the dossier that will make things difficult to manage later on in the product's lifecycle
e.g. if the acessory-power box ends up being associated with a certain size of device, we will then have problems to extract it, or register it on other markets where that size is not marketed.
Or if we end up with a separate risk management file for the accessory and the software, then the interconnected risks might get duplicated and the wording, or scoring may end up being different between the risk management file for the device and the risk management file for the accessory.


*the software is not a medical device in itself.


Under the FDA, will these be able to be submitted all together in a single dossier via the 510(k) pathway as a "bundled device" ?


Hope the question is clear .

Kind regards,
Thomas

 

[shimonv]

Hi Thomas,
Obviously, you gave this a lot more thought than anyone in the cove would...
1. Regarding CE, the short answer is you should speak with your notified body because they have the final say.
I have seen situations where the NB insisted on separating the active from the non-active components, i.e. two separate Technical Documentations, even though they fulfill the same intended use. I think the reason for that is (i) the V&V for active is very different from the V&V for non-active devices, and (ii) they have separate reviewers for active and non-active devices.
2. Regarding Risk Analysis, you can have one Excel file with different tabs, one for each category. Just a thought.
3. Regarding Software, since it is a part of an accessory which is connected to the implantable somehow, I don't see how it is not IEC 62304 compliant. SW error can affect the use of the device... something for you to consider.
4. Regarding FDA, in theory, I think it's possible to bundle everything in on submission. But that would make the submission very big, the review process longer, and you won't be able to submit until you finish the V&V for all sizes and accessory. You may want to consider breaking it up to several submission and plan the V&V accordingly. Also, in the case of FDA, I recommend that you go for a pre-submission meeting. It will give you all a peace of mind to get input directly from FDA. After all, it sounds like a very big project and, as you wrote, you don't want to make a fatal error.

Good luck,
Shimon