Difference between intended purpose and intended use of the device

[Krishna Priya T]

Hi,

I'm working on IVDR. gone through Annex-XIII, in which it is mentioned that "specification of the intended purpose of the device; and specification of the intended use of the device" to be mentioned in performance evaluation.

Whether intended purpose and intended use is different?? Previously i worked assuming both are same.

kindly help me to find out the difference between both the terms.

Thank you

 

[FoGia]

Hi,
These concepts are indeed different but get regularly mixed up.
The best source of information I've identified until now comes from the MEDDEV 2.7/1 rev 4, page 35:

intended purpose of the device
- exact medical indications (if applicable)
- name of disease or condition/ clinical form, stage, severity/ symptoms or aspects to be
treated, managed or diagnosed
- patient populations (adults / children / infants, other aspects)
- intended user (use by health care professional / lay person)
- organs / parts of the body / tissues or body fluids contacted by the device
- duration of use or contact with the body
- repeat applications, including any restrictions as to the number or duration of re-
applications
- contact with mucosal membranes/ invasiveness/ implantation
- contraindications
- precautions required by the manufacturer
- single use / reusable
- other aspects

Hopefully this is a concept that will get clarified in future guidance.

 

[L_O_B]

Hi Krishna Priya T,
The intended purpose has its definition in the regulation so I will not address that.

The German national working group for the implementation of MDR and IVDR (NAKI) by the fenderal ministry of health (Bundesministerium für Gesundheit) also identified this item and published an FAQ on manufacturers' obligations: Link
This is in German so here is my unofficial translation of their interpretation of the intended use (bestimmungsgemäße Verwendung):
The specification of the intended use shall include all detailed information required for the safe and efficient use of the device including intended user, reference material, use environment, indications, contra-indications, measuring inaccuracies etc.
So basically they want the use specification.

To also address their disclaimer: This is NOT a binding statement but just their current thinking about this topic.

 

[stealthdog]

Hi,

I'm working on IVDR. gone through Annex-XIII, in which it is mentioned that "specification of the intended purpose of the device; and specification of the intended use of the device" to be mentioned in performance evaluation.

Whether intended purpose and intended use is different?? Previously i worked assuming both are same.

kindly help me to find out the difference between both the terms.

Thank you

The source for the confusion is the European Commission itself.
There is no definition of 'intended use' in MDD 93/42, including the 2007/47 amendments.
“Intended purpose” is defined in Article 1 paragraph 2(g), as follows
“(g) ‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials;”.

This is also true for AIMDD Art. 1.2.f

Now have a look at this:
MEDDEV 2. 1/ 2.1 of February 1998 states the following in the Background section:
"Definition of "intended use" (EC Directive 93/42/EEC): "The intended use means the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or promotional materials".

How about that?

Regulation 2017/745 defines “intended purpose” (Article 2 paragraph 12):
“(12) ‘intended purpose’ means the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation;”

Appendix 3 of the 2.7/1 rev.4 guidance provides the list of the subsections/paragraphs/sections that should be defined under "intended purpose", and I really have a hard time to see the difference between that and the translation of what the German RA are currently considering the definition of "intended use".

We can continue with the fact that GHTF/SC/N4:2012 (Edition 2) defines the following:
Intended Purpose: The use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.
GHTF/SG2/N54R8:2006

Intended Use / Purpose: The objective intent of the manufacturer regarding the use of a product, process or service as reflected in the specifications, instructions and information provided by the manufacturer.
GHTF/SG1/N045:2008 / GHTF/SG1/N68:2012 / GHTF/SG1/N70:2011 / GHTF/SG1/N77:2012
GHTF/SG5/N6:2012

But the ugly truth is that the intended use thingy probably is an implant from the US FDA 21 CFR 801.4, amended back in 2017, which actually uses this term.

Sec. 801.4 Meaning of intended uses.

The words intended uses or words of similar import in 801.5, 801.119, and 801.122 refer to the objective intent of the persons legally responsible for the labeling of devices. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It may be shown by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he received the devices, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses. But if a manufacturer knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a device which accords with such other uses to which the article is to be put.

So, good luck with thinking it over

 

[Ronen E]

@stealthdog, very comprehensive and true summary of the situation!!!
Awesome style too... Welcome to posting here and I hope to see more of yours in the future.

Cheers,
Ronen.

 

[FoGia]

To come back on my previous comment, the IMDRF seems to be taking over the listing of characteristics that actually define intended purpose/use from the MEDDEV 2.7/1 rev 4 according to the draft on clinical evaluation that is currently under consultation: Proposed update to Clinical Evaluation documents. On page 21 we can read:

Intended use:

• indications for use, including the disease or condition the device will diagnose, treat, prevent, cure or mitigate
• the severity and stage of disease
• patient population (age, gender, anatomy, physiology, other aspects)
• the site of application to/in the body (organs, parts of the body, tissues or body fluids contacted by the device)
• type of contact (contact with mucosal membranes/ invasiveness/ implantation)
• duration of use or contact with the body
• environment of use (e.g. healthcare facility, home)
• intended user (use by health care professional / lay person)
• repeat applications, including any restrictions as to the number or duration of reapplications

other aspects

You can notice that in that list is left out WHAT the device actually does, which according to the document would better fit in the technical description (principles of operation?):

Technical:

• design (e.g. dimensions and design tolerances; how the different components of the device system work together)
• material (e.g. chemical formulation, additives, processing such as forged, state such as crystalline)
• specifications and properties (e.g. physicochemical properties such as type and intensity of energy, wavelength, porosity, particle size, viscosity, nanotechnology, specific mass, atomic inclusions such as nitrocarburising, oxidability, tensile strength and degradation characteristics)
• deployment methods (if relevant)
• critical performance requirements
• principles of operation
• other aspects

This starkly contrasts with the vast majority(all?) of intended use statements I've seen so far.
I don't understand how regulators can botch such a central concept.

 

[Ronen E]

@FoGia Indeed there is a conceptual problem here.

If you go over a large number of Intended Use statements in 510k summaries (for example), you'll notice that there's a huge variation in their coverage and style. I assume this is both due to variation in the nature of devices / companies / approaches, and the lack of clarity about this issue. But the fact remains that the FDA accepted that huge variation.

There is a big difference between what a device is intended to achieve (in terms of both clinical endpoints and the physiological mechanisms to get there); how a device is technically intended to operate in order to achieve that; and how the user is expected to behave to facilitate all that. These are all things regulators, manufacturers and users need to know and understand, however forcing all of them under a single term seems to me unnecessary and actually damaging.

 

[dgrainger]

On page 21 we can read:

This is a section about 'Comparability' - "The examples given below are potential aspects for consideration with respect to comparability."

This is the same as 'Demonstration of equivalence' - (P32 of MEDDEV 2.7/1 rev 4.)

The device description/ intended use/purpose is in Appendix G - P29

 

[stealthdog]

@stealthdog, very comprehensive and true summary of the situation!!!
Awesome style too... Welcome to posting here and I hope to see more of yours in the future.

Cheers,
Ronen.

Finally resolved in MDCG 2020-6 (first indent on page 6):
‘intended use’: The MDR defines ‘intended purpose’, but not ‘intended use’. ‘intended use’ should be considered to have the same meaning as ‘intended purpose’.

 

[Ajit Basrur]

Finally resolved in MDCG 2020-6 (first indent on page 6):
‘intended use’: The MDR defines ‘intended purpose’, but not ‘intended use’. ‘intended use’ should be considered to have the same meaning as ‘intended purpose’.

Thank you stealthdog.

Here is the link and attachment that was referenced. DocsRoom - European Commission