Eight German associations are calling for changes to be made to the European In Vitro Diagnostics Regulation (IVDR) in a bid to support the continued use of laboratory-developed tests. The ...

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 rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

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 ...

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 ...

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 ...

China and the EU retaliated with their own tariffs. While Trump claimed foreign leaders are eager to negotiate, his remarks have sparked criticism, especially as markets and economies suffer from ...

US bourbons like Maker’s Mark and Jack Daniels whiskey were initially in the EU crosshairs, but member nations including France, Italy and Ireland successfully pushed for their removal to ...

After several weeks of consultations between member states, EU Commission and industries, the EU adopted retaliatory measures on Wednesday against US tariffs on EU steel and aluminium. EU member ...

However, EU representatives have expressed concern that the Trump administration seems determined to fundamentally alter global trade practices while showing limited interest in compromise.