Indications, Intended Purpose, Claims, and Medical Device Regulation 2017/745:What Are the Differences, and What Are the Implications?

In the field of medical devices, the terms indications, claims, and intended purpose/intended use play a fundamental role in the design, marketing, and safe use of these devices. These terms are often confused or used interchangeably, even by industry professionals. However, these concepts are not synonymous, and a lack of understanding can not only complicate regulatory processes but also lead to misunderstandings among end users.
Understanding the nuances that distinguish these terms is more than just a matter of vocabulary: It is a crucial step to ensure that each medical device complies with the General Safety and Performance Requirements (GSPR) while meeting user needs in a clear and safe manner. In this article, we will explore these three key concepts to better understand their implications.

1. Understanding the Definitions and Terminology

The definitions of the terms “indications” and “intended purpose” are outlined in Article 2 of Medical Device Regulation (MDR) 2017/745 and in Section 1.2 of the MDCG 2020-6 guidance document. The term “claims”, on the other hand, is not explicitly defined in MDR 2017/745; instead, it is implicitly framed by several concepts introduced in the regulation. Understanding the differences between these terms is essential so that manufacturers correctly define them and ensure the compliance of their devices with the regulation.

Indication: The When and How of a Medical Device

The MDCG 2020-6 guidance defines the medical indication as “the clinical condition to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified, or controlled by the medical device”. It describes the situations in which a medical device should be used and is typically found in the device’s instructions for use or product labeling. It relates to the pathology, medical condition, or health problem for which the medical device was developed. The indication answers the question: “For which pathology(ies)/medical condition(s)/clinical state(s) is the device used?”. For example, a hip prosthesis might have an indication such as “the treatment of degenerative or post-traumatic osteoarthritis”, while a seawater nasal spray might be indicated for “managing nasal congestion in cases of rhinitis related to upper respiratory tract infections”.

It is important to distinguish between medical indications (where the device is used for diagnosis or treatment) and non-medical indications (where the device is used for other purposes, such as aesthetics, as defined in Annex XVI of MDR 2017/745).

It is also worth noting that some products may not have an indication (e.g., products intended for disinfecting or sterilizing medical devices).

Intended Purpose: The Why of a Medical Device

Under MDR 2017/745, the intended purpose refers to “the use for which a device is intended according to the information supplied by the manufacturer on the label, in the instructions for use, or in promotional or sales materials, and as specified by the manufacturer in the clinical evaluation”. It describes the intended use of the medical device and the specific actions it is designed to perform. It answers the question: “For what purpose is the device used?”. The intended purpose of a medical device directly stems from its indication but focuses on how the device achieves its clinical goal. Returning to the example of the hip prosthesis, the intended purpose might be “total or partial replacement of the hip joint”, while for the seawater nasal spray, it might be “nasal irrigation”.

Claims: The Promise of a Medical Device

The term “claims” is not explicitly defined in MDR 2017/745. However, this concept is inherently linked to the obligations manufacturers must meet regarding the performance, safety, and accuracy of the information provided about their devices. A medical device’s claims are the statements made by the manufacturer regarding the device’s characteristics, performance, or benefits. These claims are often highlighted in brochures, advertisements, or technical data sheets, but they must be carefully formulated to avoid misleading or non-compliant promises (see our article on this topic). Claims answer the question: “What are the benefits resulting from the use of the medical device?”.

In general, claims can be categorized into two types: non-clinical claims and clinical claims.

• Non-clinical claims pertain to the intrinsic characteristics of the device and may relate to its design or use.
• Clinical claims relate to clinical performance, clinical safety, or clinical benefits and their impact on patient health. Clinical claims are subject to stricter regulatory requirements and must be supported by clinical data obtained from human studies (except in specific cases). Each claim must be backed by an adequate level of clinical evidence, including data from both non-clinical and/or clinical studies. Claims must remain consistent throughout the device’s documentation, including the technical file, instructions for use, and promotional materials.

These three fundamental concepts—indications, intended purpose, and claims—are essential for ensuring the regulatory compliance of a medical device. They not only define the product’s intended use but also ensure that the information communicated to users is clear, consistent, and compliant with MDR 2017/745. Among these concepts, the distinction between non-clinical and clinical claims deserves particular attention.

2. How to Navigate Non-Clinical vs. Clinical Claims

Not all medical devices necessarily have clinical claims. The nature of the claims depends on the type of device and its intended use.

Non-Clinical Claims

Non-clinical claims pertain to the physical, mechanical, or functional aspects of the device. These may include characteristics like durability, ergonomics, ease of use, or specific technical specifications. They address elements of non-clinical performance (e.g., wear resistance for a hip prosthesis or physiological pH for a seawater nasal spray) or non-clinical safety (e.g., biocompatibility for a hip prosthesis or preservative-free formulation for a seawater nasal spray).

To substantiate non-clinical claims, manufacturers must provide evidence from laboratory tests, performance trials, technical evaluations, or rationales. These elements are part of the clinical evaluation assessed by notified bodies to ensure the device’s market entry or continued market presence.

Clinical Claims

Les revendications cliniques sont de trois types :

Clinical claims are of three types:

• Clinical performance, measuring, for example, the effectiveness of the device in treating a medical condition, reducing symptoms, or preventing complications (e.g., for a hip prosthesis, the improvement in hip joint mobility, measured using a recognized mobility score such as the Harris Hip Score; and for a seawater nasal spray, the reduction in nasal congestion, measured by an efficacy score on a numerical scale from 0 to 10, where 0 corresponds to no reduction and 10 to a very significant reduction).
• Clinical safety, measuring, for example, complications associated with the medical procedure performed and the use of the device (e.g., for a hip prosthesis, a complication rate below 5%; and for a seawater nasal spray, the absence of serious side effects/adverse effects related to the use of the nasal spray).
• Clinical benefits, corresponding to the positive impact of a device on patient health management or public health (e.g., for a hip prosthesis, a 40% improvement in quality of life after surgery, measured using an SF-36 questionnaire; and for a seawater nasal spray, an improvement in quality of life, measured by quantifying the improvement in ease of breathing/reduction in nasal congestion on a numerical scale from 0 to 10, where 0 corresponds to no improvement and 10 to a very significant improvement).

These different types of clinical claims require evidence from clinical studies or robust clinical data to demonstrate their validity. This evidence must be of a sufficient level to prove that the device meets the claims stated by the manufacturer. The concept of the level of clinical evidence is detailed in the MDCG 2020-6 guidance. It should be noted that certain medical devices do not have clinical performance or safety claims, such as a hydroalcoholic gel or tubing, which instead have non-clinical claims (e.g., elimination of 99.9% of bacteria or resistance to bending, respectively). These products often have an indirect clinical benefit, for example, associated with the medical procedure in which they are used. The indirect nature of the clinical benefit must be duly justified.

3. Proper Identification of Claims: A Key Challenge for Manufacturers

For manufacturers, effectively highlighting their product’s benefits is crucial for market promotion. Device claims must be aligned with the target market but, more importantly:

• They must be identified during the design phase of the device.
• They must be determined alongside the indication and intended purpose to ensure consistency within the documentation.
• They must be evaluated to determine their nature (non-clinical or clinical) and the level of evidence required to support them.
• For clinical claims, supporting clinical data must be generated solely within the device’s intended use.

By identifying and justifying all claims, manufacturers gain:

• Consistency in documentation: Marketing materials, regulatory documents, and the technical file for the device are harmonized: The indications and intended purpose are clearly identified, and claims are properly analyzed in the technical documentation.
• Credibility with customers and regulatory bodies: Promotional documents (e.g., portfolios, product sheets) are more precise, data is sourced, and results are verifiable.
• Faster market entry: The manufacturer has already gathered the necessary evidence, identified gaps between claims and available data, and can more easily address missing data or adjust claims.
• Efficiency and cost savings: Properly identifying claims during the design phase and aligning them with the target market allows manufacturers to avoid lengthy and costly clinical studies that are potentially unnecessary or irrelevant in supporting the device’s claims.

4. How to Determine Indications, Intended Purpose, and Claims? A Strategic Approach

A comprehensive literature review of clinical data on similar products can help identify potential indications, intended purpose, and claims as early as the design phase. While there is no specific recommendation for drafting a state-of-the-art literature review during the design phase, it is advisable to follow the requirements of the MEDDEV 2.7/1 Revision 4 guidance, which outlines the clinical evaluation process.

This exhaustive literature review ensures that safety and performance claims for the medical device are based on reliable scientific and clinical evidence recognized by the medical community. These same criteria should be used in preclinical or clinical studies conducted on the evaluated device to compare its performance with similar reference devices.

Conclusion

Mastering the concepts of indications, intended purpose, and claims is essential for ensuring the regulatory compliance and safety of medical devices. Identifying these elements during the design phase allows manufacturers to ensure robust technical documentation, consistency across documents, transparent communication with stakeholders, and compliance with MDR 2017/745 requirements. By adopting a holistic vision of the device and the above essential concepts, manufacturers can not only meet regulatory requirements but also accelerate market entry, enhance competitiveness, and build lasting trust with customers and partners.

Need help?

Our clinical evaluation/investigation experts within our CRO are here to advise and assist you with:

• Choosing the best clinical strategy for your product,
• Defining your indications, intended uses, and non-clinical and clinical claims,
• Drafting your clinical evaluation and post-market clinical follow-up documents,
• Conducting part or all of your clinical investigations through our scientific and medical writing, clinical operations, data management, and biostatistics departments,
• Training your teams through our Qualiopi-certified training center TREE (Training Experience by Efor)

Contact us at the following address for all of your inquiries: onedt@efor-group.com