IVDR Survival Guide Part 1: A Deep Dive Into Classification, Clinical Evidence, And Performance Requirements

By Matthew Nowland and Caroline Perez

To strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices, the European Union released a five-year in vitro diagnostic regulation (IVDR) transition plan in May 2017. While several dates have since been extended to allow for the challenging nature of the transition from the old in vitro diagnostic medical devices directive (IVDD), the new IVDR officially went into effect on May 26, 2022.

Although manufacturers were granted a lengthy timeline to adjust, many have shared that they are still struggling to comprehend the IVDR requirements. For comparison, the IVDD is noted to only have a few genuinely innovative requirements. Essential criteria, technical documentation and specifications, conformity evaluation, registration, Notified Bodies, the European database EUDAMED, and vigilance are examples of similarities.

For IVDR, however, two completely new requirements have been introduced: 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. The main difference is that that will significantly affect compliance is the new, 4-tier IVD classification system.

Have common questions concerning the IVDR product classification system addressed and learn how to comply with the new clinical evidence and performance expectations by accessing this blog.