Unraveling the Complexity of the In Vitro Diagnostic Regulation (IVDR)

The landscape of healthcare and medical devices is always changing. One of the latest changes is the European Union’s In Vitro Diagnostic Regulation (IVDR), which started in May 2022. The IVDR (Regulation (EU) 2017/746) has brought in stricter rules and has had a big impact on the industry that makes in vitro diagnostic (IVD) tests. But, this new regulation is also quite complex, and those involved in the industry need to understand and work with these complexities.

A Shift in Classification
One of the big changes brought by the IVDR is how it categorizes IVD devices. Before the IVDR, most tests (80-90%) were self-certified, meaning manufacturers could declare conformity without involvement of a notified body.  But now, only a small portion of tests (10-20%) can be self-certified.

The IVDR introduced a risk-based classification system, grouping IVD devices into four categories – A (lowest risk), B, C, and D (highest risk). With this new system, most IVD devices will require assessment by a notified body. This significantly increasing the regulatory burden on manufacturers.

Enhanced Post-Market Surveillance
Another layer of complexity comes from IVDR’s emphasis on post-market surveillance (PMS). Under the IVDR, manufacturers will need to collect and analyse data on the quality, performance, and safety of an IVD device throughout its lifecycle. This proactive, continuous process is much more rigorous than the previous reactive approach, requiring manufacturers to establish systematic methods for gathering post-market information and using it to maintain a risk management system and update their technical documentation.

Increased Clinical Evidence Requirements
IVDR also imposes stricter requirements on the clinical evidence needed to demonstrate an IVD device’s safety and performance. Manufacturers must conduct performance evaluation studies, following a continuous process throughout the entire lifecycle of the IVD device. This requirement not only applies to new IVD devices but also to those already on the market. Therefore, manufacturers must reassess their existing devices to ensure they meet these new evidence requirements, adding a new dimension to the regulatory challenge.

The Role of Economic Operators
The IVDR introduces new responsibilities for economic operators, such as manufacturers, importers, and distributors. Under the regulation, each actor in the supply chain bears responsibility for the IVD devices they handle. They are required to have systems in place for traceability and vigilance, which means understanding the entire lifecycle of the product, from production to distribution.

IVDR’s Impact on Laboratories
The regulation further extends its scope to laboratories. They will be required to comply with the IVDR if they manufacture in-house devices for use within their own premises. These in-house tests, which were previously exempted, now fall under the IVDR, creating additional responsibilities and challenges for laboratories.

IVDR compliance is a complex task requiring resources, expertise, and consideration of increased clinical and post-market requirements, device reclassification, and the impact on various stakeholders. It also necessitates understanding broader implications, such as effects on product portfolios, market access timelines, and costs. Navigating these intricacies might involve strengthening regulatory teams, updating technical documents, and setting up strong post-market surveillance systems.

The IVDR represents a significant shift in the regulatory landscape for IVDs in Europe, aiming to increase patient safety and transparency in the IVD market. Although the transition to the IVDR is challenging, it provides an opportunity for manufacturers to enhance their devices’ quality, safety, and reliability, ultimately delivering improved patient outcomes.