Description: The introduction of the IVDR has reshaped the landscape for IVD manufacturers, increasing the safety of the devices, but also complicating the regulatory system. Different challenges exist at different stages, and this presentation will focus on the challenges in the early phase. It starts with the device and establishing its intended use. The next step is determining if the device can actually be classified as an IVD, which in some cases can be surprisingly difficult. Also identifying the intended user of the device or determining if something is considered an accessory, can be complicated. This presentation provides real-world borderline cases and examples of these type of challenges from a Notified Body’s perspective.
The next step is building up the technical documentation. For manufacturers with multiple devices, the path to CE certification involves not only regulatory compliance but also strategic planning. We will discuss approaches for setting up technical documentation and the pros and cons of combining controls or similar devices into a single technical file. These strategies will be considered from various perspectives, including their impact on review timelines, costs, and regulatory outcomes. Through practical examples and strategic insights, this presentation offers a roadmap for turning regulatory challenges into opportunities for efficiency and clarity.
Learning Objectives:
Upon completion, participants will be able to list the steps to be taken in the early phase of technical file build up, and the challenges that may arise.
Upon completion, participants will be able to describe different approaches and the advantages and disadvantages of adding multiple similar devices in one technical dossier.
.jpg "Ines Labugger, PhD (she/her/hers) photo")