Explaining IVDR Classification for In Vitro Medical Devices
The In Vitro Diagnostic Regulation (IVDR) is a European Union regulation that governs in vitro diagnostic medical devices. Its primary objective is to establish a risk-based classification system for these devices, ensuring enhanced regulatory scrutiny. Under the IVDR, most devices require a conformity assessment by a Notified Body. At AF Pharma Consultants, we specialize in assisting medical device manufacturers with IVDR classification and compliance, ensuring a smooth and efficient path to market.
Understanding the IVDR: A New Era for In Vitro Diagnostic Devices
The IVDR represents a significant departure from its predecessor, the In Vitro Diagnostic Directive (IVDD). It came into effect on May 26, 2022, and introduces a comprehensive framework for regulating in vitro diagnostic devices in the European market. Notably, an estimated 80-90% of IVDs on the EU market will need to undergo a conformity assessment by a Notified Body.
Differentiating IVDD and IVDR
Compared to the IVDD, the IVDR is far more expansive and rigorous. It employs a risk-based classification system governed by a set of rules that all IVD manufacturers must use to classify their devices. This system takes into account both patient and public health risks associated with in vitro diagnostic devices. To navigate this new regulatory landscape effectively, it is crucial for IVD manufacturers to understand the IVDR classification system.
IVDR Classification System: A Comprehensive Overview
Similar to other medical devices regulated under the EU Medical Device Regulation (EU MDR), the IVDR classifies IVD devices based on their risk level. However, due to the potential risk of transmissible agents in biological material used with in vitro devices, the IVDR classification also considers public health risks. The classification system encompasses four risk classes:
Class A: Devices with low patient and public health risks. Examples include specimen receptacles, laboratory instruments, and buffer solutions.
Class B: Devices with moderate patient risk and/or low public health risk. This category includes self-testing IVDs, such as pregnancy tests, fertility tests, and cholesterol tests. It is also the default classification for IVDs not covered by any other rules.
Class C: Devices with high patient risk and/or moderate public health risk. Class C devices are used for detecting infectious agents without high propagation risk or detecting agents with the potential to cause severe disability or death in case of an erroneous result.
Class D: Devices with high patient risk and high public health risk. This category includes IVDs that detect or are exposed to life-threatening transmissible agents or agents with a high risk of propagation.
As experts in IVDR compliance, AF Pharma Consultants can guide IVD manufacturers in accurately classifying their devices according to the IVDR framework.
The Seven Classification Rules Under IVDR
To determine the risk class of an IVD device, the IVDR outlines seven classification rules, accompanied by guidance on their implementation. These rules assist IVD manufacturers in accurately classifying their devices. They cover various scenarios and considerations, including the detection of transmissible agents, blood grouping or tissue typing, self-testing devices, laboratory instruments, and specimen receptacles. For the complete text of the rules, refer to Annex VIII in the IVDR.
Leveraging AF Pharma Consultants for Successful IVDR Compliance
Navigating the IVDR requirements and achieving CE Marking for IVD devices can be a complex process. With the majority of IVDs now requiring a conformity assessment by a Notified Body, it is crucial for manufacturers to partner with experienced consultants like AF Pharma Consultants. Our team of experts provides comprehensive support, including IVDR classification, development of quality management systems, technical file or design dossier audits, and assistance with the Declaration of Conformity. With our guidance, you can streamline your transition to IVDR compliance and ensure timely market access for your in vitro diagnostic devices.
Contact AF Pharma Consultants today to embark on your successful IVDR compliance journey.