Why Does Your Product Exist? Defining Your Device's Intended Purpose
One of the most important documents, and perhaps the decisive one, in developing a medical device under the MDR in Europe is the Intended Purpose.
Even so, many startups tend to write it offhandedly, ignore it at critical stages, or leave out essential elements.
Let's break down the meaning, structure and impact of the Intended Purpose, and I will give you practical pointers for getting it right from the earliest development stage, so you can avoid costly regulatory complications later on.
What is the Intended Purpose, and why does it matter so much?
The Intended Purpose is a formal definition of what your product is meant to do, who it is intended for, when, how, and under which limitations or warnings.
The Intended Purpose is the basis for all the regulatory and clinical documents, from risk analysis reports to the benefit-risk analysis, clinical documentation and the technical documentation.
Without a clear Intended Purpose, your product has no direction, and the regulator will not be able to approve it.
Definitions of the key terms
Intended Purpose: the medical purpose of the device
A clear, formal and comprehensive description of why the device exists, what it is meant to do, under which conditions, and for whom.
The Intended Purpose covers all the medical, clinical, environmental and usage aspects that need to be taken into account. It must be written early in development, because it is the basis for the entire conformity assessment process, from risk assessment to the technical documentation and clinical evidence.
For example:
"Device intended for non-invasive monitoring of heart rate in adult patients during physical rehabilitation"
Indication: the medical indication
A description of the clinical condition or medical problem the device is meant to address, for example chronic pain, bleeding, cardiac arrest or pressure ulcers. The Indication always focuses on a disease, an injury or a physiological condition.
It is not a functional goal but an answer to the question: which medical problem is the device intended for?
It should therefore appear clearly as part of the Intended Purpose document, but the two terms are not interchangeable.
Intended Use (not explicitly defined in the MDR)
The term "Intended Use" often appears in internal documents, instructions for use (IFU) or evaluation reports, but it is not formally defined in the MDR.
According to the guidance document MDCG 2020-6, it is recommended to treat it as equivalent to the Intended Purpose, meaning it describes the same information functionally, although usually in a marketing or instructional format.
What does a proper Intended Purpose include?
According to MDR Article 2(1), the Intended Purpose should include the following elements:
Indication(s): the medical or clinical condition the product is intended for. This is the indication that clarifies in which medical circumstances and for which specific problems the device should be used, for example diagnosing cardiac arrest, monitoring high blood pressure, or improving respiratory function in COPD patients.
Population: a description of the group of people the device is intended for, including patients, professional or lay users, age, physiological condition and other relevant characteristics, for example children with type 1 diabetes, intensive care physicians, or older home users with limited motor function.
Contraindications: medical, clinical or technological situations in which using the product is not safe or not recommended, meaning the circumstances in which the patient could be harmed or the use would bring no benefit. For example, the product must not be used in people with an implanted pacemaker, or in children under the age of two.
Conditions of use: the physical, clinical or environmental conditions under which using the device is proper and safe. This includes definitions such as frequency of use, duration, sequence of operations, environmental conditions (humidity, temperature), and suitability for use in particular situations, for example single use only, for use in clinics only, or intended for use during physical activity only.
Warnings: specific warnings the manufacturer must state to ensure safe use. These may include potential risks, side effects, technical or medical limitations, and precautions for careful use, for example "Do not use during pregnancy," "May cause skin irritation with prolonged contact," or "Not for use in MRI devices."
Environment: a description of the physical and clinical environment in which the product is intended to operate. This can include a hospital, a clinic, the user's home, a sterile environment, heat or humidity conditions and so on, for example intended for use under sterile conditions only, or for home use only.
Users: a description of who operates the product, whether medical professionals (such as physicians or nurses), the patients themselves, lay caregivers or technicians. It is important to clarify the level of training required to use the device safely and effectively, for example intended for use by trained medical staff only, or for self-use by the patient.
How do you word the Intended Purpose correctly?
The authorities require wording based on defined keywords from the regulation. For example:
Medical functions: diagnosis, prevention, monitoring, alleviation
Clinical conditions: disease, injury, physiological state, pathological process
Examples of correct wording:
"Device intended for non-invasive monitoring of glucose levels in adult patients with type 2 diabetes, for use at home by the patient."
This is precise wording that includes a medical function (monitoring), a clinical indication (type 2 diabetes), a population (adult patients) and a use environment (home use).
"Device intended for alleviation of knee pain in patients with osteoarthritis, to be used by physiotherapists in outpatient clinics."
This wording includes a medical purpose (alleviation), a clinical condition (osteoarthritis), a professional user (physiotherapists) and an environment (outpatient clinics).
Avoid inconsistent combinations of a medical function (such as Monitoring or Diagnosis) and a clinical indication (such as an injury or a disease). A mismatch between them will look to the regulator like a lack of coherence, which makes it harder to carry out a valid clinical evaluation and may contradict your risk documentation.
For example:
If you state that the product is intended for "reducing anxiety" but link it to a function such as "Treatment of infection," there will be a gap between the clinical goal and the type of intervention.
A product defined as "Monitoring of chronic pain" whose Intended Purpose states "diagnosis of neuropathy" is confusing and needs to be corrected so that the function and the indication fully match.
A product without a clear Indication
Some products, such as disinfection solutions for non-invasive medical devices, are a typical example of a regulatory challenge:
if no medical indication for use (Indication) is clearly defined for them, meaning it is not stated which clinical condition or problem they are intended for, they may be classified more strictly.
For example, such a product may fall under Class IIa according to Rule 16.2 of the MDR, even if it is non-invasive, simply because its specific clinical use and the population it is intended for were not made clear.
The important message here is that even if your product is technologically "simple," you need a precise definition of its medical purpose to avoid unexpected complications with the Notified Body.
Alignment with the clinical evaluation and risk management
One of the common failures is a mismatch between the Intended Purpose and:
The clinical evidence
The risk analysis
The definitions of users and use environments
The benefit-risk analysis
All of these must be fully consistent with the Intended Purpose you defined. Otherwise the documents will not support each other, and the notified body will require corrections.
Summary
Write the Intended Purpose at the earliest development stage
Build it in as the basis of the technical documentation and the risk management reports
Use consistent language and terms taken from the MDR
Check that all the clinical and regulatory documents are aligned with it
Keep it light, with a concise, clear and focused version