Intended Purpose under MDR for Medical Devices

When you start developing a medical device, you have a reason, a problem that you want to solve. One of the first things you need to think about is: what is my device supposed to do and how is it supposed to achieve this task? This is the onset of determining an intended purpose of your device. And even though it sounds like a very obvious step, it does have far reaching consequences as it will determine the claims you make and the regulatory pathway to follow in order to obtain market approval.

What is "Intended Purpose" under EU MDR?

Defining an intended purpose for a medical device is an absolutely critical step in the development and marketing of a medical device. It's the starting point for many decisions to come.

Intended purpose is defined in Article 2 (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;”

The first consequence of the Intended Purpose is whether or not your device actually is within scope of the EU 2017/745 Medical Device Regulation or not. In other words, the intended purpose will define whether your device is a medical device or something else.

A second direct consequence of the Intended Purpose is the classification that will be applicable to your device. It's the intended use that will determine whether your device will be a Class I, IIa, IIb or III. Based on this, different requirements will apply in order to obtain market approval.

The Intended Purpose is as well a text that will define the labelling, instructions, promotional or sales materials and that will come back in many different places of the technical documentation.

The intended purpose is usually a short statement of two or three sentences that focuses on what the device is intended to be used for.  It is a required item in the Technical Documentation (Annex II, 1.1)

(a) general description of the device including its intended purpose and intended users;

The Intended Purpose is not something that exists on its own. It's closely linked to other statements that need to be provided according to the same Annex.

(c) the intended patient population and medical conditions to be diagnosed, treated and/or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;

(d) principles of operation of the device and its mode of action, scientifically demonstrated if necessary;

Written together, these three statements (a), (c) and (d) should provide the basis for developing two additional statements required by Annex II, 1.1;

(e) the rationale for the qualification of the product as a device;

(f) the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;

Intended purpose vs intended use: What's the difference?

Intended use and Intended purpose are two terms that are used and there seems to be confusion about the difference and whether there is a difference or not.

Neither the 93/42/EEC (MDD) nor the EU 2017/745 (MDR) defined the term "intended use", but both used Intended Purpose. The exact wording of the definition did differ slightly between the two:

• MDD definition of intended purpose: ‘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

• MDR definition of intended purpose: '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

However, the MEDDEV guidance 2.1/2.1 of February 1998 states the following:

"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".

 So by this, the European Commission might have created the confusion between both terms. 

MDCG 2020-6 gives an answer to the question about the difference between both under the section "Additional terms not defined under MDR Article 2": 

‘intended use’: The MDR defines ‘intended purpose’, but not ‘intended use’. ‘intended use’ should be considered to have the same meaning as ‘intended purpose’

Both terms are used in different guidance documents. 

Where the actual confusion and mixing of terms originates from is hard to tell. It could be that it's because of 21 CFR Part 801.4, which actually refers to the term intended use.

The words intended uses or words of similar import in §§ 801.5, 801.119, 801.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or 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. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for a device approved, cleared, granted marketing authorization, or exempted from premarket notification based solely on that firm's knowledge that such device was being prescribed or used by health care providers for such use. 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 or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.

The importance of intended purpose

As mentioned before, the importance of writing a correct intended purpose of a device cannot be understated. Therefore it's advisable to have people specialized in both the medical field in which the device will be used as well as regulatory affairs work together to draft a meaningful and correct Intended Purpose statement.

Having this statement will allow an organization to define a regulatory strategy and plan for proper conformity assessment.

Whether it is in the risk management documentation, the clinical documentation or in the post-market surveillance documentation, the intended purpose or intended use should be defined in the same way everywhere.

Whenever the intended use of a device is being changed, it requires a full re-evaluation of the documentation and a notification to the regulatory agencies that approved the device. It's a must to have proper document control and good traceability within the Quality Management System to ensure that the intended purpose is adapted everywhere when needed.

Conclusion

Whether you call it intended use or intended purpose, this statement is one of the corner stones that will determine your regulatory pathway. It will influence the applicable legislation, the risk classification and everything going from there. Therefore, it's very important to involve people with the right expertise to write a clear and correct intended use for your device.