The CE Marking approval indicates that a medical device meets the requirements of the European Medical Devices Directive. Until now, Materialise’s personalized devices made use of the custom-made ...

IVDR compliance is a critical milestone not only for regulatory readiness, but for the long-term sustainability of ...

In Part 2 of our ‘Battery Shorts’ series, we look at the conformity assessment and CE marking requirements under the new European Union Batteries Regulation, which have applied since 18 August 2024.

Since the European Union’s main aims include consumer protection and ensuring product safety, you might be forgiven for thinking that the EU’s rules in those areas would be clear and straightforward.

This article will examine market access outside the EU/EEA based on reliance and recognition. For countries outside the European Union (EU) and European Economic Area (EEA), regulatory reliance and ...

Lumea’s Viewer+™ software is now CE marked under IVDR for clinical use across Europe, making Lumea the most versatile ...

SAN DIEGO, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Beam Global, (Nasdaq: BEEM), a leading provider of innovative and sustainable infrastructure solutions for the electrification of transportation and energy ...

PARIS--(BUSINESS WIRE)--BrainTale, a French innovative company specialized in the development of software as a medical device for the quantitative measurement of the brain microstructure and the ...

SAINT-FERRÉOL-D'AUROURE, France, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Hexadrone SAS announces that it has obtained CE marking as well as C5 and C6 class certifications for its TUNDRA 2.1 drone. The ...