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- This summary was generated by AI from multiple online sources. Find the source links used for this summary under "Based on sources".
Learn more about Bing search results hereOrganizing and summarizing search results for you2 SourcesGreenlight Guruhttps://www.greenlight.guru/blog/intended-use-and-indications-of-useThe Difference Between Intended Use and Indications of Use (And Why ...Intended use is what you claim on your label that the device does. It’s the purpose of your device.Clin-r+https://clin-r.com/intended-purpose-intended-use-and-indications-for-use/Intended Purpose, Intended Use, and Indications for Use | Clin RIndications for Use and Intended Purpose are actually the same. The US market more commonly uses the term ‘indications for use’. However, the EU MDR uses the term ‘intended purpose… Intended Purpose and Intended Use - blog.johner-institute.com
Aug 12, 2024 · IEC 60601-1 defines the term “intended purpose” as “use for which a product, process or service according to the specifications, instructions and information provided by the manufacturer” (IEC 60601-1:2005, 3.44). ISO 14971 has revised the definition of the term in its …
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Intended Use & Purpose under MDR for Medical …
Jul 10, 2024 · Understand the Intended Use & Purpose under MDR for medical devices. This critical classification defines how a device should be used, its target users, and its clinical benefits, ensuring compliance with EU regulations and …
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"Intended purpose" vs "intended use" in the EU - finally resolved
Apr 27, 2020 · Intended Purpose: 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.
Difference between intended purpose and intended use of the …
Oct 9, 2018 · Intended Purpose: 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.
Intended Purpose, Intended Use, and Indications for Use
We should distinguish it from ‘intended purpose/intended use’, which describes the effect of a device. All devices have an intended purpose/intended use, but not all devices have an indication (e.g. medical devices with an intended purpose …
Intended Use vs Indications for Use: Difference …
Dec 2, 2022 · What’s the difference between intended use and indications for use? In a nutshell, the definitions for intended use and indications are as follows: Intended use is what you claim on your label that the device does. It’s the …
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Approval of medical devices: Intended purpose and …
The intended purpose clarifies what the product is and for what purpose it can be used. Thus, the importance of the intended purpose is obvious: it has an influence on every single aspect of the product and its approval!
The Difference Between 'Intended Use' and …
Apr 25, 2017 · "Intended use" is one of the most commonly used phrases, yet it's so often misunderstood. It is not what your device is designed to be used for or even what it could be used for. It's about what your label claims--what you say …
Intended Purpose, Intended Use, and Indications for …
Feb 3, 2023 · Your intended purpose and intended use statements are integral to getting your medical device to market. These statements help ensure your device meets regulation when used properly.
Key Considerations In "Intended Use" And …
Dec 14, 2023 · “Intended use” is paramount in deciding whether a product qualifies as a medical device. It’s also a major determinant of risk classification for a device. “Indications for use” have additional roles, particularly in setting the …
Understanding Intended Use vs. Indications of Use
Oct 11, 2023 · Two crucial statements that play a vital role in medical devices are the “Intended Use” and “Indications of Use.” These statements serve distinct purposes and hold immense significance in ensuring the safety, effectiveness, …
The translation dilemma – Intended use vs. intended purpose
Apr 28, 2023 · ‘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 …
Intended purpose – The European Union Medical Device …
The Intended purpose is best composed by a medical professional, ideally someone with experience of medical writing. It should be written for the intended user group, medical …
Intended Purpose, Intended Use and Indications for Use FAQ
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 …
MDR clinical evaluation planning - intended purpose, indications ...
Jan 5, 2022 · The EU AIMDD and EU MDD both defined ‘intended purpose’ as ‘the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in …
What is the intended use of the medical device?
Learn the difference between intended use, intended purpose and indications for use and discover how they work under the MDR.
How to build an intended purpose for MDR | Evidence
Nov 26, 2024 · In the intended purpose, you should provide two essential pieces of information concerning the user: State whether the user is a healthcare professional, a layperson, or both. …
Intended Purpose - Medical Devices - Regulatory Globe
Aug 26, 2024 · The intended purpose of a medical device or in vitro diagnostic device (IVD) is a fundamental concept in EU regulations. It plays a crucial role in device classification, …
Understanding Intended Use and Indications for Use - CENIT …
Intended use refers to the manufacturer’s intended purpose for the device and is an essential part of the device’s regulatory approval process. On the other hand, indications for use are defined …
Intended Use vs Indications for Use: Understanding the Difference
Dec 9, 2020 · Put in simpler terms, the intended use is what the purpose of your device is. Your intended use can impact the regulatory pathway that you need to follow, so it is important to be …
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