A new report by trade association MedTech Europe has revealed that the struggle for manufacturers to meet the requirements of ...

Biomerica has received CE-marking for its food intolerance tests tailored for ulcerative colitis (UC) and Crohn's disease, ...

to In Vitro Medical Devices Regulation (EU) 2017/746 (IVDR). Historically, IVD devices could be self-assessed under the 1998 Directive, meaning that manufacturers could declare that the device was ...

Inbiome Shatters Diagnostic Delays: IVDR-Certified Platform IDs Bacteria in 5 Hours Across EU Hospitals Hours, Not Days: EU Approval Accelerates 5-Hour Pathogen ID for Critical Cases Molecular Fin ...

Dutch diagnostics company Inbiome has secured the EU's In Vitro Diagnostic Regulation (IVDR) certification for its rapid bacterial identification system. This certification allows for the ...

What Is an IVDR-Compliant QMS and Why May 2025 Is Crucial Under the EU In Vitro Diagnostic Regulation (IVDR) 2017/746, having a Quality Management System (QMS) that meets the specific requirements ...

Agilent (A) announced its PD-L1 IHC 22C3 pharmDx assay has received European IVDR certification for the use as a Companion Diagnostic to aid in ...

SGS, the world’s leading testing, inspection and certification company, is delighted to announce the designation of SGS Belgium NV as a Notified Body (NB) under the EU’s In Vitro Diagnostic Medical ...

The PD-L1 IHC 22C3 PharmDx (Code SK006) assay is now certified for use to aid treatment decisions for patients with gastric or gastroesophageal junction adenocarcinoma.

The NanoZoomer S20MD from Hamamatsu for EU is the UKCA, IVDR, and IvDO-compliant model that is perfect for use in clinical laboratories and hospitals. It is possible to load directly from Sakura ...

Amsterdam, the Netherlands – April 11, 2025 – Inbiome, a pioneering Dutch diagnostics company, announced today that it has received IVDR (In Vitro ... across the EU for rapid bacterial ...

announced today that it has received IVDR (In Vitro Diagnostic Regulation) certification from the European Union for its revolutionary rapid bacterial identification system. This milestone authorizes ...