The European Commission has proposed another extension to the deadline for compliance with the In Vitro Diagnostic Medical Devices Regulation (IVDR), a new regulatory framework for diagnostics like ...

Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the ...

DigiCure: Legal insights at the intersection of Technology and Life Sciences and Health Care On 4 May 2026, the European Commission adopted Commission Implementing Regulation (EU) 2026/977, ...

The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions planned for the Medical Device Regulation (MDR) and In Vitro Diagnostics ...

IVDR: where are we now in molecular testing? How IVDR implementation is progressing in molecular biology laboratories in different European countries IVDR, the new EU legislation for in-vitro ...

Key opportunities include expanding knowledge on PRRC role integration, understanding MDR and IVDR compliance, leveraging third-party PRRC services, and enhancing Quality Management Systems. The ...

The Irish Health Products Regulatory Authority (HPRA) has published a Guide for Distributors of Medical Devices (“Guide”) in which the HPRA provides useful recommendations concerning the obligations ...

The new In Vitro Diagnostic Regulation (IVDR) has been defined as one of the most significant changes in the EU legislation for In Vitro Diagnostics in the past 20 years. Due to the nature of the ...

BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), a leader in artificial intelligence (AI)-powered cancer diagnostics, today announced it has received In Vitro Diagnostic Medical Devices ...

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced that previously CE-IVD marked instruments, kits, and reagents were released as IVDR Class A on May 26, 2022, ...

Mechelen, Belgium, 02 June 2025 – Biocartis NV (“Biocartis”), an innovative molecular diagnostics company, is pleased to announce that its Idylla™ EGFR Mutation Test has received the European Union ...

The MarketWatch News Department was not involved in the creation of this content. IdentiClone(R) Dx IGH is the first IVDR-certified assay for the detection of clonal immunoglobulin gene rearrangements ...