Intended Purpose

What is the intended purpose?

The intended purpose of a medical device is the specific medical function that the device is designed and manufactured to perform.

MedDev Central uses the term “intended purpose” rather than “intended use” to avoid confusion. In some regulatory systems, the two terms are synonymous (e.g., in Europe). In other regulatory systems, “intended use” is considered separately from “indications for use” (e.g., the U.S.A.). The term “intended purpose” bridges this gap.

The intended purpose statement is the most important document accompanying a medical device. It is the basis on which a medical device’s regulation, reimbursement and use are determined.

Who defines the intended purpose of a medical device?

The medical device manufacturer defines the intended purpose and is responsible for ensuring that it is communicated clearly and accurately.

What is included in the intended purpose?

MedDev Central uses the term “intended purpose” to cover the intended use, clinical indication, patient population, treatment objective, outcomes, users and settings for which a device is designed.

The intended purpose statement typically includes:

• Intended use(s): The overall purpose of the device, including use objectives and health outcomes. Indication(s): The diseases or medical conditions that the device is designed to diagnose, prevent, monitor, or treat. This includes a description of the patient population and any specific aspects of the indication that are important to its use.
• Intended user(s): The people using the device. This may include healthcare professionals such as doctors, nurses, or specialists. Potential end-users can also include laypersons, patients and carers.
• Setting(s): The locations where the device is designed to be used. These could include clinical settings such as hospitals or clinics, ambulatory care, or home-based/remote locations. The setting is usually tightly associated with the intended users.
• Contraindications and warnings: Any conditions that may interfere with the device’s ability to perform its intended purpose safely.

The intended purpose statement should be clear and precise and based on the device’s intended use in diagnosing, preventing, monitoring, treating, or alleviating disease or injury.

Why is the intended purpose important?

The intended purpose is the primary criterion for qualifying and classifying medical devices. It guides the scope of regulation for medical devices. Regulatory approval is conferred based on the evidence provided by the manufacturer that the device performs its intended purpose safely. The intended purpose is included in the technical documentation submitted to regulatory authorities for conformity assessments. Each authority has different requirements for technical documentation, and the intended purpose statement may appear several times in different sections. The structure of the statement may differ between authorities. For example, the US FDA requires explicitly separate intended use and intended indication statements.

It also determines market access conditions, including reimbursement, pricing, and device marketing. Sometimes, the intended purpose is called “label claims” (at least in colloquial language) because it is displayed on the label of a medical device. Any marketing claims are tied to the evidence supporting the label claims and, therefore, to the intended purpose statement. The intended purpose statement is the most important document associated with a medical device because it forms the basis of its value proposition and commercial viability.

Most importantly, the intended purpose is that healthcare professionals, procurement professionals, and users rely on this information to understand the appropriate use of the device and to make informed decisions about its application in patient care.

How should the intended purpose be communicated?

Medical device manufacturers must accurately define and communicate their devices’ intended purpose. This information is crucial for regulatory approval, market access and ensuring the device is used for its intended medical purposes.

The intended purpose should be displayed on the device’s label. Medical device labels include the product packaging, instructions for use (IFU), and any accompanying documentation such as operations manuals.

It should be displayed clearly so that it is easy for users to understand. The actual wording of the intended purpose may be different on different levels of packaging. For example, on the outer packaging label, it may be a brief description or a statement of the device’s primary function. The intended purpose may be explained in more detailed IFUs, technical manuals and documentation that provide in-depth information about the device’s design, operation, maintenance, and troubleshooting.

Any updates or changes to the intended purpose should be appropriately documented and communicated to regulatory authorities and users. As a medical device’s regulatory status is intimately linked to its intended purpose, any changes typically trigger a regulatory resubmission. Payers may also reconsider medical device reimbursement status or pricing based on changes to the intended purpose.

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