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.

The UKCA mark was introduced in the Great British (GB) market to replace the European CE mark following Brexit. Products which require a CE mark in the EU must comply with the UKCA marking regime if ...

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

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 ...

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 ...

Beam Global announced that its products, including EV ARC™, BeamBike™, BeamWell™, and BeamPatrol™, have received the CE mark, which signifies compliance with European Union health, safety, and ...

(MENAFN- GlobeNewsWire - Nasdaq) The introduction of new Post-Market Surveillance regulations and UKCA marking processes presents key opportunities for medical device manufacturers to align compliance ...

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

MINNEAPOLIS, July 19, 2024 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, ...

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of patient-centric clinical-grade blood collection solutions, today announced it received CE Mark certification for its Tasso+™ device, a ...