Custom made medical devices - Wheelchairs

James

Involved In Discussions
#1
Hi

I will be working in the NHS in the UK, implementing ISO13485 in a community rehabilitation centre. The centre manufacturers custom made devices. I have a few questions:

In the case of, for example, a wheelchair that needs some adaptations for a user with particular disabilities, how would this be grouped as a product (its different to the standard wheelchairs) and documented in the QMS? It is a mass produced item that has been customised.

Also, in what instances would a more detailed technical file need to be opened for custom made devices, rather than just a device statement?

Thanks

James
 
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James

Involved In Discussions
#3
Hello,

are you sure those wheelchairs are custom made devices? Usually a custom made device is specific for a single patient, devices which are mass produced and then get some augmentations are not custom made devices.
Yes, I agree that the definition suggests that a mass produced product (eg a wheelchair) that has been adapted to meet the needs of a specific user is NOT a custom made device, but that being the case, what is it? Taking a risk-based approach, would documenting a 3rd party manufactured device that has been adapted for a particular user be the SAFEST way to deal with this scenario? If not, whats the alternative? I would imagine the wheelchair manufacturers would no longer provide warranty on a device that had been significantly adapted. I guess to some extent, detail is key here.
 

Pads38

Trusted Information Resource
#4
I would tend to agree that your modified wheelchairs do not meet the definition of 'Custom made device'.

However, if the chairs are only being used by your rehabilitation centres patients then you are not 'placing the device on the market'. Effectively, the device remains under your control and it is considered 'in-house manufacture' and not bound by the MDD.

You may want to get a definitive answer from here:

[email protected]
 

James

Involved In Discussions
#5
I would tend to agree that your modified wheelchairs do not meet the definition of 'Custom made device'.

However, if the chairs are only being used by your rehabilitation centres patients then you are not 'placing the device on the market'. Effectively, the device remains under your control and it is considered 'in-house manufacture' and not bound by the MDD.

You may want to get a definitive answer from here:

[email protected]
Thanks. However, the products are leaving the unit (ie, they are not used in a secure / inpatient environment) and although it may not constitute 'placing on the market', it is certainly 'putting into service'?

I emailed the mhra months ago... no reply.. I guess they are busy!
 

Ronen E

Problem Solver
Staff member
Moderator
#6
I'd have suggested looking to the MDR for answers rather than the MDD, but with Brexit looming maybe neither...
 

dgrainger

Trusted Information Resource
#7
Have you considered Article 16? Your adaptations may not be considered as creating a new device:

1. A distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a) makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b) changes the intended purpose of a device already placed on the market or put into service;
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in point (30) of Article 2, assembles or adapts for an individual patient a device already on the market without changing its intended purpose.....
 
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