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.

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, …

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 …

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 …

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 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 …

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 …

May 26, 2025 · EU IVDR is also commonly referred to as EU IVDR 2017/746 or simply Regulation (EU) 2017/746. EU IVDR aims to ensure the safety, performance, and reliability of in vitro diagnostic …

The in vitro diagnostic regulation (IVDR) is a new set of regulations that govern the clinical investigation, production and distribution of in vitro diagnostic medical devices in Europe.

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 …