Intended Purpose, Intended Use, and Indications for Use FAQ
Q: Why is the "Intended Purpose" important for medical devices under EU MDR?
A: “Intended Purpose” holds significant importance in the development and marketing strategy of medical devices under EU MDR. It essentially defines what the device is, its purpose, and aligns with regulatory requirements, impacting various aspects of device validation and marketing claims.
Q: How frequently is "Intended Purpose" referenced in the EU MDR?
A: “Intended Purpose” is referenced 87 times in the EU MDR, serving as a cornerstone for demonstrating regulatory compliance.
Q: What does “Intended Purpose” signify?
A: It establishes the device as medical equipment, justifies its positioning on the market, and forms the basis for conformity assessment.
Q: What if the "Intended Purpose" is misaligned with Clinical Development Plans (CDP) or Business Development Plans?
A: Misalignment of “Intended Purpose” with business plans can lead to regulatory challenges and hinder market reach. Changes to the “Intended Purpose” are considered substantial, as per Article 120 and MDCG 2020-3, resulting in potential resource-intensive efforts to rectify the issue.
Q: How can manufacturers ensure alignment between "Intended Purpose" and business plans?
A: Manufacturers should ensure alignment between “Intended Purpose” and business plans by linking them back to their Clinical Development Plans (CDP). Properly defining the “Intended Purpose” ensures strategic alignment across various departments, supporting regulatory compliance and future marketing claims.
Q: What are the key differences between "Intended Use" and "Indications for Use" for medical devices?
A: “Intended Use” and “Indications for Use” are terms critical to understand in medical device development. While “Indications for Use” and “Intended Purpose” are synonymous, “Intended Use” focuses more on the medical purpose, detailing how the device is used in various medical procedures and conditions.
Q: How can you ensure alignment between "Intended Purpose" and usability engineering processes?
A: Manufacturers can ensure alignment by applying usability engineering methods throughout development. Clear definitions of terms related to “Intended Purpose” and usability, along with ongoing documentation updates, contribute to regulatory compliance and safer medical practices.
Q: How do you ensure compliance for your "Intended Purpose"?
A: Manufacturers should focus early on regulatory considerations to design and articulate accurate “Intended Purpose” statements. Understanding the difference between clinical endpoints, technical operations, and user behaviours is crucial. Proper alignment between “Intended Purpose” and regulatory requirements facilitates smoother market entry and ongoing compliance.
Q: How does the US market terminology differ from the EU MDR for "Intended Purpose" and "Indications for Use"?
A: In the US market, “Indications for Use” is a common term, while the EU MDR predominantly uses “Intended Purpose.” Despite the difference in terminology, they essentially refer to the same concept.
Q: Is it really important to understand "Intended Purpose" and "Intended Use"?
A: Manufacturers should grasp the significance of both “Intended Purpose” and “Intended Use” as they impact various aspects of device design, development, and regulatory pathways.
Q: What are the definitions of "Intended Purpose," "Intended Use," and "Indications for Use" according to medical device regulations?
A:
The definitions are as follows:
Intended Purpose / Indications for Use: The use for which the device is intended according to the data supplied by the manufacturer on the labelling, instructions, or promotional material.
Intended Use: Focuses on the medical purpose, including the medical indication, procedure, and device’s mode of action.
Indications for Use: Refers to the clinical condition that the device is intended to prevent, diagnose, monitor, treat, alleviate, or control.
Q:What information should be included in statements regarding "Intended Purpose" or "Indications for Use"?
A: Statements regarding “Intended Purpose” or “Indications for Use” should encompass key information about the device, including the procedure it is intended for, its mode of action, indications, patient population, and intended user.
Q: How does "Intended Use" provide additional detail about a medical device?
A: “Intended Use” offers more specific information about how the device is used, including its type, field of medicine, sterility status, and reusability.
Q: Why is it important to ensure clarity and definitiveness in statements regarding "Intended Purpose" and "Intended Use"?
A: Clarity and definitiveness in these statements are crucial as they influence the risk classification of the device and ensure regulatory compliance.
Q: Do all medical devices need to define "Intended Purpose," "Intended Use," and "Indications for Use"?
A: While not all devices need to define all these terms, they must have clear “Intended Use” and “Intended Purpose” statements. “Indications for Use” may not apply to all devices, especially those with broader applications.
Q: How can "Indications for Use" impact the regulatory pathway for a medical device?
A: “Indications for Use” can alter the regulatory pathway for a device, potentially leading to changes in its classification. For example, expanding the device’s indications may upgrade its classification from Class IIb to Class III, depending on regulatory rules.
Q: What is an example of how "Indications for Use" can affect the classification of a medical device?
A: For instance, if a scalpel’s indication or intended use broadens to include the central nervous system or circulatory system, it may be subject to a higher classification under specific regulatory rules, such as Classification Rule 7.
