Understanding the Concept of “Intended Purpose” in the IVDR

In the complex world of the In Vitro Diagnostic Regulation (IVDR), the term ‘intended purpose’ plays a central role. Introduced by the European Union, the IVDR (Regulation (EU) 2017/746) has set new and stringent rules that regulate the In Vitro Diagnostic (IVD) industry. In this article, our goal is to simplify and clarify the idea of ‘intended purpose’ as outlined, and explore how it affects IVD device manufacturers.

What is the ‘Intended Purpose’?
At its core, ‘intended purpose’ is defined by how the manufacturer intends the IVD device to be used. It includes information such as the medical conditions or diseases the device is designed to detect, the population the device is intended for, and the circumstances under which the device should be used. This ‘intended purpose’ must be clearly stated in the device’s labeling and documentation and is a crucial factor in classifying the device under the IVDR’s risk-based system.

The Importance of ‘Intended Purpose’
Understanding and defining the ‘intended purpose’ is crucial for manufacturers. The intended purpose shapes many elements of the device’s lifecycle, from its design and development to its marketing and post-market surveillance.

The IVDR requires manufacturers to provide sufficient clinical evidence to support the claimed intended purpose. This means manufacturers must carry out studies and tests to prove that the device can accurately and safely do what it is intended for.

Impact of ‘Intended Purpose’ on Device Classification
The IVDR introduces a new risk-based classification system for IVDs, ranging from Class A (lowest risk) to Class D (highest risk). The ‘intended purpose’ is instrumental in determining the device’s risk class. For example, a device intended to provide critical information for the diagnosis of a life-threatening disease is classified as higher risk than a device intended for general health information.

How to Define the ‘Intended Purpose’
The “intended purpose” should be determined early in the device development process and must be based on a clear understanding of the needs of the user and the patient. It should be explicitly stated in the device’s documentation and include:

1. What the device is intended to detect or measure
2. How the device should be used
3. Who the device is for (target population)
4. The benefits that the device provides

In conclusion, ‘intended purpose’ is a key concept in the IVDR that influences the entire lifecycle of an IVD device. A well-defined ‘intended purpose’ ensures that the device meets the IVDR’s stringent safety and performance requirements and delivers meaningful and safe results to patients.

While the IVDR has added layers of complexity to the IVD industry, it also offers a chance for manufacturers to thoroughly evaluate their devices and ensure that they are truly serving the needs of patients. By clearly defining the ‘intended purpose’, manufacturers can not only comply with the IVDR but also improve patient care, one diagnostic test at a time.

If you’re finding the IVDR tough to navigate, don’t worry – QRcompliance is here to help. Visit our website at www.qrcompliance.nl. We also provide a selection of templates in our online shop to assist you in setting up compliant documentation seamlessly. Let QRcompliance guide you through the intricacies of the IVDR.

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