IVDR
Top Five Articles on 360Dx Last Week: Dx Companies' Plans for POC Testing; IVDR Rollout; More
Last week, readers were most interested in a story about the hurdles faced by companies bringing routine testing at the point of care.
A year after the EU's In Vitro Diagnostic Medical Device Regulation took effect for new products, its implications for manufacturers and diagnostic labs are starting to emerge.
MedTech Europe Calls for Reforms to IVDR, MDR Regulations
The trade group said the current regulations governing medical devices, including in vitro diagnostics, are unpredictable, complex, and unfavorable to innovation.
Thermo Fisher Scientific Mass Spec Dx Platform Nabs IVDR Certification
Exent Solution, an automated mass spectrometry system for diagnosing patients with monoclonal gammopathies, is now commercially available in parts of Europe.
New regulations, politics, and the economy have transformed the UK's in vitro diagnostic industry the past few years, and more adjustments are on the horizon.