If it's not a custom-made medical device... What is it? Clinician requests

CTea

Registered
#1
I've poked around on Google quite a bit trying to find an answer, but have failed miserably to find an answer. I'm trying to wrap my mind around the MDR as a whole, and this has me tripped up.

According to Article 2 (3) "mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices; "

I work with predominately Class IIb sterile, single-use (disposable) devices. We have several clinicians who request "custom devices" because they want to do XYZ procedure a different way/ from a different angle/ etc... often the requests are something to the tune of "slightly smaller", "slightly longer/ shorter", "bent this way, not that way", "Rounded, not sharp", "Sharp, not rounded"... You get the idea. I've worked with custom products before, with a different company, and I know now, that they were not really handled in a compliant way. That company eventually stopped making custom products because compliance was deemed "too difficult"- I understand that is a common theme in the industry. The custom devices that were created with my previous company, and now in my current company, often fed into (even becoming) the R&D process for a future product. Logically, I don't see a problem with this- it almost feels like iterations of design validation (albeit with very limited clinician feedback). But from a regulatory perspective, this seems like a no-no.

If adapted versions of a mass-produced device is requested by a physician to meet his/her specific requirements is not a custom-made device, then how is that sort of device regulated?

My organization works closely with clinicians, and prides itself on that. If we are to continue making devices according to clinician requests, I want us to handle these situations in a complaint manner. I'm aware I will be upsetting the apple cart as it is, I just want to know how much.
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
If it's not a custom-made device, it should be considered either a new serially produced model or an investigational device undergoing clinical trials (your reference to R&D use sounded to me more like "research" than "design validation").

The above is just my educated gut feeling, I haven't studied the MDR closely on this topic specifically for writing this post.
 

FoGia

Involved In Discussions
#3
This is an area in where current regulation, including the MDR, is lagging behind the facts. It has caught the attention of the regulators however, there is a working group at IMDRF which has opened a consultation on the subject. I would advise you to go have a look at their draft to get yourself an idea of where your devices stand in that respect and maybe it could provide you with arguments when debating with your NB.
 

pkost

Trusted Information Resource
#4
I think the directive is quite clear on this:

‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner's written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.
The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.
Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user ►M5 shall not be ◄ considered to be custommade devices;
What about the specific patient requires "slightly smaller", "slightly longer", "bent this way"? this sounds like meeting the specific requirements of the medical practitioner which is clearly stated as not being a custom device and therefore must go through regular conformity assessment
 

yodon

Staff member
Super Moderator
#5
My initial thought regarding the indicated clause was for things like dental implants and now for things like 3d printed bone scaffolding. The intended use, method of use, etc. doesn't change.

The customizations you mention seem to be changing the way the device was designed to be used. That would, to me, introduce the potential for different risk scenarios that had not been considered and wouldn't fall under this clause.

Definitely an interesting topic!
 

CTea

Registered
#6
Thank you all for your input. I agree about the risk profiles. It's just supremely frustrating to say what something isn't, but not say what it *is*...

It feels like showing a veterinarian a picture of an animal that looks something like a cat, and them saying "That's not a cat. Have a nice day." :confused:
 

pkost

Trusted Information Resource
#7
it is a medical device which is required to undergo conformity assessment.

Following your analogy, it sounds like you have gone to the vet to ask them if your cat is a sphynx cat because you desperately want one, but the vet is giving you an answer you do not want to hear....it is not a sphynx cat, it is just a standard cat.
 

James

Involved In Discussions
#10
So basically - as long as custom made / in-house manufactured devices are managed within an appropriate quality management system (such as 13485), that is enough to demonstrate compliance with the regs?
 
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