Approaching IVDR Compliance: Key Considerations for In Vitro Diagnostic Devices

With the European Union’s In Vitro Diagnostic Regulation (IVDR) deadline quickly approaching, it is crucial for manufacturers to understand the transition from the In Vitro Diagnostic Directive (IVDD) to the new regulation. In this article, we will explore the final steps in preparing for IVDR compliance, key factors to consider, and the necessary documentation requirements to meet the new standards. 

What is IVDR?
The In Vitro Diagnostic Regulation (IVDR) EU 2017/746, which replaces the IVDD, is designed to improve the transparency, safety, and quality of in vitro diagnostic medical devices within the European market. It focuses heavily on the entire product lifecycle, emphasizing supplier management and stricter quality management systems. Unlike the IVDD, the IVDR introduces more stringent requirements for documentation and regulatory oversight, including mandatory conformity assessments by notified bodies for higher-risk devices. 

Technical Documentation: A Critical Component of IVDR Compliance
One of the first steps toward IVDR compliance is understanding your product’s classification. IVDR classifies devices into categories based on their risk level, and the regulatory burden varies accordingly. Devices in classes B, C, and D require conformity assessments by notified bodies, meaning self-certification is no longer an option for these products. To meet the regulation, thorough technical documentation must be submitted. 

To begin preparing your documentation, the primary question to address is the intended use of your product. This is a key compliance requirement under IVDR and may impact your registrations with other regulatory agencies, such as the FDA or regulatory bodies in Australia and China. As you prepare for IVDR, be mindful of how the additional details required may affect these registrations in other markets. 

The Role of Software in Device Classification
Under the new IVDR, software plays a significant role in the classification of diagnostic devices. If your device includes software, ask yourself these key questions: 

• Does the software simply run the instrument, or does it interpret results from an assay? 

• Does the software make a medical decision based on the results? 

The answers will influence how your device is classified and what documentation is needed for compliance. The software’s role in interpretation, whether it provides clinical outputs or assists with data analysis, must be considered in your submission. IVDR also requires a post-market surveillance plan, including periodic safety update reports, which were not as emphasized under previous regulations. 

Performance Evaluation Plan and Post-Market Surveillance
The performance evaluation plan for IVDR includes both analytical and clinical studies and is crucial for supporting your device’s specifications and requirements. For example, questions like, How was the assay cutoff determined, and what does it mean? are vital to answering when preparing the plan. Additionally, ensuring your post-market surveillance covers all aspects of the device, including software, complaints, and potential supplier changes, is crucial for IVDR compliance. 

As part of the performance evaluation, your documentation should include reports on the clinical performance study plan, rationale for validation, and analysis of any changes made to the device over time. Notified bodies will expect updated documents that reflect the evolution of the device, ensuring ongoing compliance throughout its lifecycle. 

Pitfalls and Common Mistakes to Avoid
As you prepare for the transition to IVDR, there are a few key pitfalls to avoid: 

1. Misclassifying Your Device: The classification of your device directly affects the regulatory burden. Devices that only move samples or assist with simple tasks may qualify as class A devices, which have fewer documentation requirements. However, if the classification changes to class B or higher, the regulatory burden increases significantly. 

1. Inadequate Post-Market Surveillance Plans: Make sure your post-market surveillance is robust and includes software, instrumentation, and complaints. Monitoring and reporting any issues that arise post-market is essential to meeting IVDR standards. 

1. Failure to Update Documentation: All technical documentation, including performance evaluation plans and clinical study reports, must be up-to-date and aligned with the new regulations. 

How to Ensure IVDR Compliance and Manage the Transition
Transitioning to the IVDR can be complex, but with proper guidance, the process can be manageable. BioBoston Consulting is here to support your journey to IVDR compliance. We offer expert advice on documentation preparation, classification, performance evaluation plans, and post-market surveillance to ensure your devices meet the new regulatory standards. 

Get Expert Help for IVDR Compliance with BioBoston Consulting
Ensure your devices are ready for the transition to IVDR. BioBoston Consulting provides tailored solutions to help manufacturers meet the new regulatory requirements efficiently. Do not risk falling behind—contact BioBoston Consulting today for expert guidance and support throughout your IVDR compliance process.