May 6, 2017 · Directive 98/79/EC of the European Parliament and of the Council (3) constitutes the Union regulatory framework for in vitro diagnostic medical devices.

Aug 16, 2025 · The In Vitro Diagnostic Regulation (Regulation (EU) 2017/746), commonly known as IVDR, is a comprehensive legal framework established by the European Union. It aims to ensure the …

The IVDR “brings EU legislation into line with technical advances, changes in medical science, and progress in law-making” (1). IVDR has binding legal enforcement throughout all EU member states, …

Regulation (EU) 2017/746 (IVDR) is a regulation of the European Union on the placing on the market and putting into service of in vitro diagnostic medical devices (IVD), repealing Directive 98/79/EC …

May 25, 2025 · Explore the timeline for compliance with in the IVDR process, ensuring your products meet regulatory requirements on time. Read detailed guidance on documentation submission …

(New) First publication of MDCG 2025-6 - FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act …

The aim of the IVDR is to further establish a well-regulated and smoothly functioning market for in vitro diagnostic medical devices (IVDs; Box 1) within the European Union (EU) that is better aligned with …

The IVDR aims to improve device traceability, enhance clinical evidence, and ensure rigorous post-market surveillance to safeguard patient safety. The IVDR framework is structured around key …

The In Vitro Diagnostic Regulation (IVDR) is the current European Union (EU) regulatory legislation for placing in-vitro diagnostic devices on the EU market, making them available and putting them into …

May 6, 2017 · However, a fundamental revision of that Directive is needed to establish a robust, transparent, predictable and sustainable regulatory framework for in vitro diagnostic medical devices …