Clinical Research: Phase 1 - Phase 4

IVDR Survival Guide: Understanding the IVDR Product Classification System and Complying with the New Clinical Evidence and Performance Expectations

The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for the challenging nature of the transition from the old in vitro diagnostic medical devices directive (IVDD), the new IVDR officially applies as of May 26th, 2022.

Despite this long timeline, manufacturers still struggle to understand the IVDR requirements. This guide addresses common questions concerning the IVDR product classification system and how to comply with the new clinical evidence and performance expectations. Factors influencing the growth of APAC oncology clinical trials.

What distinguishes the IVDD from the IVDR?

Only a few requirements of IVDD are truly novel. Similarities include essential requirements, technical documentation and specifications, conformity assessment, registration, notified bodies, the European database EUDAMED, and vigilance.

Post-market surveillance was always necessary but has recently been upgraded. The same goes for unique device identification (UDI) now extended to Europe. In addition, the relationship among economic operators is changing slightly. For example, notified bodies (NBs) are now explicitly agents of the competent authority, and can’t be as consultative as they were in the past.

Two completely new requirements for IVDR include: at least one person in the organization must be responsible for the company’s regulatory compliance, and patients receiving genetic testing results must have access to counseling.

However, the main difference that will significantly affect compliance is the new, four-tier IVD classification system. Despite the added work, the new IVDR is an improvement on the current directive. It is a more comprehensive approach that aligns the classification of IVD medical devices with other medical devices and international practice, as advocated by the Global Harmonization Task Force.