2017/746 - EN - Medical Device Regulation - EUR-Lex
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.
In Vitro Diagnostic Regulation (IVDR)—Frequently Asked Questions
What is the IVDR? The In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR) is a new regulation that will create a robust, transparent, and sustainable regulatory framework that “improves clinical …
In Vitro Diagnostic Regulation (IVDR) | BSI
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 …
Regulation (EU) 2017/746 (EU IVDR)
(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 …
What Is the IVDR Regulation and Its Key Requirements?
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 …
MDR 2.0, IVDR 2.0: What the Commission is planning
4 days ago · Many manufacturers hope that MDR 2.0 / IVDR 2.0 will bring substantial relief. But are these hopes misguided? Here is an overview.
In Vitro Diagnostic Regulation (IVDR) Overview | Morulaa
Sep 11, 2025 · The IVDR (In Vitro Diagnostic Regulation – EU 2017/746) is the European Union’s new law that controls the safety and quality of in-vitro diagnostic devices tests and instruments used to …
The New EU Regulation on In Vitro Diagnostic Medical Devices ...
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 …
IVDR Requirements: What You Need To Become Compliant
Nov 12, 2025 · Let's look at the most important IVDR requirements and how to implement them in an efficient way for your company.
Understanding IVDR Compliance: A Guide for Life Sciences
5 days ago · IVDR compliance refers to adhering to the regulations set forth by the European Union concerning in vitro diagnostic devices. These regulations establish standard practices for risk …