Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision …

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 …

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 …

Are you looking for the latest consolidated text of the EU IVDR? Click here. Listed below are some of the most recent publications supporting the implementation of the EU IVDR. Update of …

Discover BSI Group's expertise in the In Vitro Diagnostic Regulation (IVDR) and how we support compliance and quality assurance.

The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market.

2025年1月29日 · Simply put: the IVDR is the EU's new guiding regulation specifying the safety, integrity and quality requirements for any medical device that performs an in vitro diagnostic …

The IVDR came into application on 26 May 2022 but also provides for a transitional period for certain devices.

The IVDR uses a risk-based classification system with classes ranging from A (the lowest risk) to D (the highest risk). Under IVDR requirements, a Notified Body must inspect Class A-Sterile …

The IVDR intro­duces a risk-based clas­si­fi­ca­tion sys­tem sim­i­lar to the MDR. Risk class­es range from A to D (A being the low­est and D the high­est risk class). Class B, C and D prod­ucts …