Profusa, Inc. (Nasdaq: PFSA), a digital health company pioneering next-generation biosensing technologies, today announces that it has submitted its response package to questions received from its ...

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 ...

In its letter to the European Commission, the European Organisation of Technical Assessment (EOTA) and stakeholders in the construction sector, the ERC advocates the adoption of CE marking through the ...

The European Commission issued new rules on 24 September 2013 that establish a new EU process for designating and monitoring Notified Bodies, establishing the basis for withdrawing such a designation ...

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.

Company focusing resources on near-term commercial milestones; European CE Mark process and Healthcare Research revenue opportunities Process intended to evaluate strategic growth alternatives to ...

Cerus’ Notified Body, TÜV-SÜD, has completed the review of the clinical module for the CE Mark submission for INTERCEPT Red Blood Cells (RBCs) CONCORD, Calif.--(BUSINESS WIRE)-- Cerus Corporation ...

PARIS--(BUSINESS WIRE)--Regulatory News: CARMAT (FR0010907956, ALCAR), designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for ...

CE mark awarded for aXess™ at record speed, underpinned by strong EU pivotal trial data Xeltis advances ahead of schedule to commercialization aXess™ reduces the need for vascular access interventions ...

Femasys Inc. announced the achievement of CE mark certification for the FemBloc delivery system, marking it as the first regulatory approval in the world for a non-surgical permanent birth control ...

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.