Spotlight Medical, a Paris-based oncology diagnostics company, today announced that myStage Dx has received CE marking under the European Union In Vitro Diagnostic Medical Devices Regulation (IVDR, ...

Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "EU MDR and IVDR: Key Updates and Compliance Strategies for 2025 (Aug 6, 2025)" training has been added to ResearchAndMarkets.com's offering. The EU ...

MedTech Europe has voiced broad support for proposed changes to the In Vitro Diagnostic Regulation (IVDR), welcoming many proposals and pushing for the strengthening of some revisions.

SANTA CLARA, Calif.--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 ...

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, ...

The progressive rollout of the In Vitro Diagnostic Medical Devices Regulation (IVDR) is now official, after the European Parliament and Council adopted an amendment setting new dates of application ...

The European market for medical devices is large and diverse–including products as different as contact lenses, pacemakers, breast implants and ultrasound machines, plus in vitro diagnostics such as ...

Mechelen, Belgium, 10 March 2026 - Today, Biocartis announced that its Idylla™ CDx MSI Test has received Class C companion diagnostic (CDx) certification under the EU’s IVDR1 as a CDx for colorectal ...

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 regulation, which replaces the earlier IVD Directive 98/79/EC, introduces more rigorous safety, performance, and quality requirements, ensuring that in vitro diagnostic medical devices placed ...