Cancer Core Europe (CCE) Lecture - Understanding the IVDR: New Regulatory Landscape for In Vitro Diagnostic Devices in EU Health Institutions
Veranstaltungsdatum:
30.09.2024, 15:00 Uhr
Weitere Veranstaltungstermine:
Es liegen keine weiteren Termine für diese Veranstaltung vor.
Sprache:
englisch
Beschreibung:
Welcome to the next Cancer Core Europe (CCE) Lecture, hosted by VHIO:
Understanding the IVDR: New Regulatory Landscape for In Vitro Diagnostic Devices in EU Health Institutions
Speaker: Deborah Grazia Lo Giacco, PhD in Cellular Biology, Quality Specialist
Moderator: Ana Vivancos, Group Leader of VHIO´s Cancer Genomics Group
Monday, September 30, 2024 - Time: 3 - 4 pm CEST
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.
What is Cancer Core Europe (CCE)?
Cancer Core Europe is a consortium of seven leading cancer centres (www.cancercoreeurope.eu). CCEs members are driven by a strong will to reshape the cancer research model to ultimately increase the European Union?s competitiveness as a place to conduct cutting-edge research that?s translated to the clinic to deliver more personalized medicine.
What is the content and aim of the CCE Lecture?
The CCE Lecture series is a CCE-internal event, which educates and informs about state-of-the-art research within the seven centers and is aimed to increase awareness among partners about each other?s activities and potential for collaboration.
Veranstaltungsort:
Online via Zoom
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