MDR - Question around software accesories

Cali_Kitson

Starting to get Involved
#1
Hi everyone,

I am an avid reader of the forums but I am yet to post.

Without giving away any sensitive information, I recently took up a new position at a start up and I am working with a totally unfamiliar product.

Unfortunately, it seems following analysis of the companies tech file, the consultant who was paid to do the work which would facilitate CE marking of this product has not done their job correctly. You would be amazed at how little has been done and the poor quality of the work.

An example of what I am talking about is as follows:

The consultant drew up a DoC as per the MDR, allowed the CEO to sign off (who is unfamiliar with RA and thus trusted the word of his high paid consultant). The consultant had not even implemented a basic QMS which would satisfy minimum requirements of the MDR for a class I product.... CRAZY! Literally, the QMS consists of empty folders... I am totally perplexed and I assume there will be bite back for person in question. I now have to implement a full QMS, where my expectation was only to be updating the QMS in order to gain 13485 certification.

OK... My question is based on my unfamiliarity of the product and I am reading the regs as we speak, however, I thought it may be useful to post here. This is my first experience of working with a product which also incorporates a software. I am starting to get my head around the regulations but still I would like some input from the experts here :)

The product is a device which is supplied with a tablet (a windows tablet - CHEWI), which would be supplied in kiosk mode and the software supplied would facilitate use of the device itself. The device could also be connected to any computer as long as the software was installed. The software itself facilitates use of a HD camera, and is also a platform for storage of images. The use of the software without the device itself would therefore be the storage of medical images and little else.

Are the software and tablet classified as accessories as per the MDR?

The fact that the consultant hasn't done their job properly has made this much more difficult to get my head around. There is no mention of the software or tablet in the (what is already turning out to be an incomplete and poorly executed) technical file, there is no mention of the software or tablet as an accessory, there is no reference to the software in the risk management files etc.

If anyone could share there expertise around what I have discussed it would be appreciated.
 
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Cali_Kitson

Starting to get Involved
#2
I would like to add, that the device could run on any platform, not just the software that we have created, therefore the device is platform agnostic.

The software provides an image from the camera only, and the image could be used to aid the HCP in diagnosis.
 

dgrainger

Trusted Information Resource
#3
Does the software fit the definition of an accessory for a medical device:
"means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);"

It isn't clear if the 'device' can work as intended without the software - can it display images if used on its own?
 
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