In-house Tests Under the IVDR

The In Vitro Diagnostic Regulation (IVDR) has also had a significant impact on clinical laboratories performing in-house developed tests (IHTs). This blog explains how these in-house test laboratories fit into the IVDR’s framework in more detail.

Understanding In-house Tests
In-house tests, also known as Laboratory Developed Tests (LDTs), are diagnostic tests that are developed and used within a single laboratory. They are typically designed for specific patient needs that cannot be met by commercially available IVDs. These may include tests for rare conditions, highly complex tests, or those required for emergency situations.

In-House Tests Under the IVDR
Under the previous In Vitro Diagnostic Directive (IVDD), in-house tests were exempt from the conformity assessment process. However, the transition to the IVDR significantly changes this scenario.

The IVDR introduced stringent regulations on in-house tests. According to the IVDR, laboratories can only continue to produce and use IHTs if they meet several conditions. Among these, they need to demonstrate that no equivalent IVD device is available on the market or that the use of an on-market IVD device is not appropriate to address the specific needs of the patient.

Moreover, the performance of in-house tests should be validated and documented. Labs must also participate in external quality assessment schemes, where available.

The Impact on Clinical Laboratories
Clinical laboratories that heavily rely on IHTs will face increased scrutiny under the IVDR. Meeting these new requirements may require substantial financial, personnel, and time investment to validate the performance of their tests and to implement quality management systems.

Moreover, IVDR compliance demands laboratories to have a greater emphasis on post-market surveillance, vigilance, and transparency. Laboratories must systematically collect and retain post-market data related to IHTs’ safety and performance and report serious incidents and safety corrective actions.

Challenges and Opportunities
These regulatory changes, undoubtedly, pose challenges to clinical laboratories. However, they also present opportunities for improving patient safety and test quality. The need for performance validation and external quality assessment encourages laboratories to ensure their IHTs are accurate, reliable, and clinically valid.

While complying with the IVDR will require a significant investment, it can also foster increased confidence in IHTs and improve their standard. This way, it will help ensure that patients continue to have access to high-quality, necessary in-house tests, and that these tests deliver reliable results.

The transition to IVDR significantly alters the regulation of in-house test laboratories, pushing them into a more rigorous regulatory framework. Although this shift can be challenging, laboratories that view these changes as an opportunity to improve the quality and safety of their tests will be better equipped to navigate this new regulatory landscape.

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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