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 …

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 …

The In Vitro Diagnostic Regulation (IVDR) is the EU’s regulatory basis for placing in vitro diagnostic medical devices on the European market.

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 …

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

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 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 …

We offer comprehensive and tailored services for in vitro diagnostic medical device compliance according to new IVDR 2017/746 requirements. Learn more.

On May 26, 2022, after a transitional period of 5 years, the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices 1 (IVDR; Table 1) will fully replace Directive 98/79/EC on in …