Intended Users & Use Environments - Alignment with Intended Purpose & Indications for Use

Hi All,

Not sure whether this should sit in the Usability, Risk Management, or EU MDR forum as it crosses all of them - but the question has cropped up through documenting the various aspects of the usability engineering file so here we are.

The topic has been raised as in documenting the intended users and use environments for specific products within the UEF, this no longer aligns with the EU Instructions for use documentation, whereby the MDR requires;

The instructions for use shall contain all of the following particulars:
(b) the device’s intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate


I'm working with families of devices with the same broad intended use for all.
Within the device families there are different products with indications for the specific medical condition that they treat under the broad intended use.

The question is regarding products that have different technical features that are not related to the medical condition being treated, but are specifically targeted for a certain user group, or use environment.
e.g.
Crutches where you may have different products in a family for various environments to ensure grip
Corrective lenses with different tints for various environments to prevent glare

Do these technical differences, and the intention that they are made for different user groups or use environments, affect the Intended use or indications for use of the device, despite the changes not being related to the medical intended use or medical indications?

The products are still intended to support a patients weight or correct deficient eyesight, and the indications of the specific devices would capture what medical reason somebody would need crutches or what specific eye condition the lens treats, and are applicable to any users, but would be "best used" by people using the devices in specific environments.


My argument is that the devices were designed with specific intention for this, and this should be reconciled in all literature, but the counter argument I'm getting is that they treat the same medical conditions, so the other factors do not need to be separated out.

Does anyone have any thoughts or comments about how I can approach this?

Cheers,

TS.

I'm sorry, but I got a bit lost. What documents are you considering updates to? What are the changes not being related to the intended use or indications?

On re-reading it I got a bit lost, too.

Let me try and clarify, and with regards to what documents require updating - potentially all, but that's what I'm trying to seek clarification on.


Devices A and B are within the same family of devices with the same fundamental design and currently have the same intended use, and same indications for use within the EU technical file and on the 510(k) clearance and in the instructions for use provided with the device.
Both devices treat the same medical condition.

Device B has technical differences within the design that make it "more suited" to a specific type of user, and that user has a specific use environment.
The advertising for the device clearly specifies this with the benefits that these users will receive over using Device A, or competitor devices.
This technical difference was developed into the product with the sole intention of benefiting this specific user group.
For further clarification, without getting into the technical details - this is not relating to different sizes of the same device, but an entirely different feature.

In preparing the use specification, where it documents "intended users" and "intended use environment" I have stated the specific intended users and use environments that the device is being marketed for based on the technical specifications.

I'm being challenged about this, and am being told that "any adults that have this medical condition can use device A or B, and both devices can be used in the same use environments, there is no restriction on what device a user chooses, so the intended users and use environments are the same for both device, but certain users may see a benefit by choosing device B over A"

Personally I believe that the User Needs document, Design Inputs document, Design Traceability Matrix, all usability engineering documentation, and product literature should reflect this user need and intended user group - but articulating this has been a challenge.

My replies are made as I imagine a circumstance in which the original device is a (right-handed) scissors, and now there is an intent to also market a left-handed scissors. I realize this is not the product under consideration, but bear with me.

ThatSinc said:

Personally I believe that the User Needs document, Design Inputs document, Design Traceability Matrix, all usability engineering documentation, and product literature should reflect this user need and intended user group - but articulating this has been a challenge.

Click to expand...

User Needs: In my scenario, there is either no change to the user needs, or there is an extension to the user needs.... depending on how the needs were originally worded. It is likely (in my scenario) that a user class was not correctly identified, or if scope was originally limited specific to righties, that you now want to expand the class to be righties and lefties.

I am also presuming (in my scenario) that during (original) user validation, or due to post-market feedback, it was noticed that some class of users could be better served by a slightly different device. To bring such a device into existence, the design outputs have to be motivated by something... the immediate predecessor is design inputs, but I can imagine a case where a single set of design inputs yields both a right-handed and left-handed set of scissors... if the engineering team is paying close enough attention to the user needs... but user needs are typically factored into input requirements to help the engineers get to a device which will pass validation. I imagine that the existing DHF (for a right-handed scissors) still covers almost all the requirements of a (new) left-handed scissors, so traceability should only need to be updated for new requirements and new testing.

If the device family is extended, I would expect the user validation to cover all elements of the family. The regulators might ask for more than I can think of, but AFAIK extending product families is easier than starting from scratch. Obviously product literature should be updated.

The only documents not mentioned (that I can think are relevant) are the Risk Management Files. Minimally, the Risk Management Plan (and Report) need to be updated to address the the now-extended product family. You can go deeper, as appropriate.

I think with the scissors analogy a more appropriate example would be the company manufacturing both left and right handed scissors in a particular style, but then adding a new product to the range in the exact same style but with the addition of a finger rest (a-la hairdressers scissors) with the intention that they are better suited for that user group. (for this example, lets ignore the fact that hairdressers scissors have many other design differences to suit their intended use)

The intended use of the product stays the same, and any user could use both types, but that feature was specifically added for a certain type of user.

Tidge said:

To bring such a device into existence, the design outputs have to be motivated by something...

Click to expand...

That's the exact point I've been making but the argument is, as above, that any user group could use the product, so the user needs haven't changed from the "all day comfortable use" user need.

Tidge said:

I imagine that the existing DHF (for a right-handed scissors) still covers almost all the requirements of a (new) left-handed scissors, so traceability should only need to be updated for new requirements and new testing

Click to expand...

Yes, 99% of the requirements are identical, and the design traceability matrix includes the clinical testing of the new product against the user need, with improved scores on all day comfort use, for the specific user group that has been targeted by the design feature.

I suppose I don't understand what is being asked. If the device is subject to design controls, then apply the appropriate design controls. I don't recommend simply trying to slip a new device onto the market without due diligence... it's better to let the regulators know in advance what you are trying to do than it is to suffer under their later scrutiny. I have no special insight into how the EU regulators will react.

Tidge said:

I don't recommend simply trying to slip a new device onto the market without due diligence...

Click to expand...

I couldn't agree more, I'm trying to ensure it gets done.

Tidge said:

I suppose I don't understand what is being asked.

Click to expand...

If a design feature of a product is developed for a specific user profile but does not affect the intended use or indications for use, and doesn't preclude other users from using the device, does this need to be specifically addressed in the usability engineering file and in the instructions for use around intended users?

All advertising, supported by clinical evidence, targets the product for the specific user profile - but currently the usability file and instructions for use are the same for both the product with the feature and without it.