This content has been archived. It may no longer be relevant
The In Vitro Diagnostic Medical Device Regulation (IVDR) – EU 2017/746 is a European regulatory framework introduced to enhance the safety and performance of in vitro diagnostic (IVD) devices in the European market. This blog will delve into the intricacies of classification under IVDR and provide a guide for manufacturers to navigate through this complex system.
IVDR Risk-Based Classification
The risk-based classification system under the IVDR has redefined the categorization of IVDs from a list-based approach (under IVDD) to a rule-based system. The new system is more comprehensive, considering the device’s intended purpose and associated risks. There are four (4) risk classes, Class A through D, with A being the lowest risk and D the highest.
Class A includes products with no or low risk to individuals or public health, such as general laboratory accessories. Class B consists of devices with low to moderate risk like cholesterol tests, Class C comprises moderate to high-risk devices, such as tests for cancer testing, and finally, Class D includes devices that present a high potential risk, for example, devices detecting the presence of transmissible agents in blood donations.
Applying Classification Rules
The IVDR provides detailed classification rules. These rules are based on the intended purpose of the IVD and the risk it could pose to individuals or public health. Manufacturers need to accurately define the intended purpose of their IVD device and then apply the relevant classification rule. The classification process involves following 7 rules to determine whether the device fits into Classes A to D. In case an IVD device could fall into more than one class, the rule resulting in the highest risk class applies.
Understanding the Consequences of Classification
The classification of an IVD device has a direct impact on the conformity assessment route that a manufacturer must follow to demonstrate compliance with the IVDR. As the risk level of the device increases, the scrutiny level in the conformity assessment process also intensifies.
For Class A devices, manufacturers can self-certify their devices after setting up a quality management system. However, for classes B, C, and D, a notified body’s involvement becomes necessary. In particular, for high-risk Class D devices, an additional assessment by a reference laboratory is required.
The IVDR introduces a more stringent regulatory approach to ensure the safety and performance of IVDs. The new risk-based classification system provides a structured way to assess and manage the potential risks associated with different IVDs. It’s crucial for manufacturers to understand the classification rules, as they directly influence the conformity assessment process and regulatory strategy. With thorough planning and preparation, manufacturers can successfully navigate the complexities of the IVDR and maintain their place in the European IVD market.
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.