Welcome to the next Cancer Core Europe (CCE) Lecture, hosted by Vall d’Hebron Institute of Oncology (VHIO).

Understanding the IVDR: New Regulatory Landscape for In Vitro Diagnostic Devices in EU Health Institutions

Speaker: Deborah Grazia Lo Giacco, Quality Specialist in Quality Unit at VHIO
Moderator: Ana Vivancos, Group Leader of VHIO´s Cancer Genomics Group

Monday, September 30, 2024 ‒ Time: 15:00 – 16:00 CET

Zoom link: https://us06web.zoom.us/j/83190996034?pwd=b3JhKN96UK5HApVxpTYhfwSu4BNXo1.1

Abstract

The In Vitro Diagnostic Medical Devices Regulation (IVDR) represents a significant overhaul of the regulatory framework for in vitro diagnostic (IVD) devices within the European Union. Enforced from May 26, 2022, the IVDR introduces more stringent requirements to ensure the safety and performance of IVD devices. A key aspect is Article 5, which outlines specific conditions under which health institutions can develop and use IVD devices internally, known as «in-house» devices. These institutions must meet rigorous standards, including quality management systems, documentation, and performance evaluation, to ensure compliance.

Health institutions face hurdles such as increased regulatory burdens, higher costs, and the need for enhanced technical expertise. However, it also offers opportunities to improve patient safety, foster innovation, and harmonize standards across the EU. Successfully navigating the IVDR will require strategic adjustments and a proactive approach to compliance, but it ultimately aims to create a more robust and transparent regulatory environment for IVD devices in the European Union.

During the lecture Deborah will delve into both the challenges and opportunities presented by the IVDR, offering insights to help health institutions navigate this new regulatory landscape effectively.

Join us!