Under IVDR 2017/746, the Performance Evaluation Report (PER) is a critical component of the technical documentation required for CE marking of In Vitro Diagnostic (IVD) devices.

Learn how in vitro diagnostic (IVD) devices can comply with IVDR and Indian MDR standards, ensuring regulatory alignment, ...

However, the iVDR-Xtreme functions like a normal disk drive and can be formatted to any file system the user desires. Now there are many ultra-compact disk drives on the market—what makes Maxell’s ...

The IVDR’s extensive requirements were adopted by the European Parliament in 2017 and must now be implemented by May 26, 2022. IVDR becomes mandatory as of May 26, 2022.

How will Tecan be tackling the IVDR regulation changes and what measures have already been carried out? Tecan has embraced this challenge, and prepared for the new IVDR regulations from the outset.

AliveDx has obtained a CE mark under the EU's in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease ...

Product line earns CE-marking under new EU IVDR framework – including QIAstat-Dx Analyzer, QIAstat-Dx Rise and panels for detection of gastrointestinal and respiratory infections ...

The IVDR framework, implemented to enhance the safety, quality, and performance of in-vitro diagnostics across Europe, introduces rigorous new requirements. Biomerica’s food intolerance products ...

IVDR certification for Guardant360 CDx is significant because it ensures continued broad access in the EU to comprehensive genomic profiling, which plays a critical role in helping biopharma ...