Custom made medical device MDD vs MDR definition

The 0racle · Oct 9, 2019

Hello everyone

My organization manufacturers sockets for patients who have lost a limb. The socket covers the patients residual limb, and is then fitted with other parts (including a hand or a foot) to create an artificial limb for the patient.

These sockets are individually made using a traditional lamination process by draping material over the cast of the patient's residual limb. As you can imagine this socket is made to the 'prescription' of the clinician and thus is a custom-made medical device, and doesn't bear a CE mark.

Two questions really....

1. Does the classification of custom made device change under the revised wording of MDD (custom made/mass produced)?

2. If we were to create 3D printed sockets, would this become a mass-produced device and hence require the application of the CE mark (class 1 device)

Thanks in advance for your thoughts.

James

Badoit · Jan 22, 2020

The 0racle said:
Hello everyone

My organization manufacturers sockets for patients who have lost a limb. The socket covers the patients residual limb, and is then fitted with other parts (including a hand or a foot) to create an artificial limb for the patient.

These sockets are individually made using a traditional lamination process by draping material over the cast of the patient's residual limb. As you can imagine this socket is made to the 'prescription' of the clinician and thus is a custom-made medical device, and doesn't bear a CE mark.

Two questions really....

1. Does the classification of custom made device change under the revised wording of MDD (custom made/mass produced)?

2. If we were to create 3D printed sockets, would this become a mass-produced device and hence require the application of the CE mark (class 1 device)

Thanks in advance for your thoughts.

James

Hello,

I have pretty much the same question regarding custom made orthotics devices, being fabricated from a cast.

Does anybody have any idea if they should still be considered as custom made devices or if it changes with MDR?

Thanks,

Ronen E · Jan 22, 2020

From the MDR:

‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.

chris1price · Jan 23, 2020

From my understanding, if the device is ordered by a physician and it is for a single named patient, then it is a custom-made device. How it is made is not important (cast, 3D machines etc) provided every one is different and for a unique patient.

FoGia · Jan 23, 2020

The situation is more complex than that, there's a IMDRF working group regarding 'personalized devices', here a consultation they had last year:
Personalized Medical Devices - Regulatory Pathways

It will take some time before this gets implemented in EU regulations, but can give an idea of where things are going.

chris1price · Jan 23, 2020

Thanks, I wasn't aware of the IMDRF working group, this is good information. I am not surprised by the recommendations for documentation, although registration of devices may be more difficult. All things to bear in mind for the future.

Badoit · Jan 23, 2020

Thank you. Very interesting.

Until the recommendations of this workgroup gets implemented, does that mean that the rules stay pretty much the same between MDD and MDR? I read the definition of custom-made in both documents and it is very similar:

MDD
“(d) ‘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 custom made devices;”

MDR
“(3) ‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. However, 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;”

Badoit · Jan 23, 2020

On thing I also wanted to ask: I found that in the UK, there is pretty clear definition of what falls into custom-made vs non custom-made regarding orthotics and prosthetics devices. I can't post the link because I don't have 5 posts but I attached a pdf.

However, I didn't find any similar document for other countries. Do you know of some place where I could find a similar information for other countries, where they details what the MDD and MDR custom-made definition means specifically for orthotics and prosthetics products?

Badoit · Jan 27, 2020

Hello,

Does anybody has an idea about that or an idea of who I could reach out to as a consultant? Preferably in the US.

Thanks!

Ronen E · Jan 27, 2020

Not in the US but I'd be glad to work with you. I'm sending you a PM.

Custom made medical device MDD vs MDR definition

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