CAB (conformity assessment body) activity picks up in EU/US medical devices MRA (mutual recognition agreement)
This article was originally published in Clinica
Executive Summary
Following the recent listing of the UK's SGS Yarsley as the first European conformity assessment body (CAB) authorised to conduct independent inspections on behalf of the US FDA, two more are close to being cleared. Another is not far behind, officials participating in the March MRA stakeholder teleconference heard. In all, ten EU CABs have shown interest in being part of the MRA process (see below).
You may also be interested in...
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add two new products, including Ryzneuta, Evive Biotechnology's treatment for chemotherapy-induced neutropenia.
Pair Of Deaths Linked To Recalled Vyaire Medical Respiratory Devices
The US FDA has labelled a recall of more than 6 million Airlife respiratory support devices class I. The recall covers devices manufactured in 2017 or earlier that can fail to provide adequate ventilation.
Over The Counter 2 Apr 2024: Analyzing The Spin-Out Trend In Consumer Health, With HBW’s Malcolm Spicer And Tom Gallen
In this episode, HBW Insight’s Europe and US editors bring their expertise to bear on the current the trend towards standalone OTC companies in global consumer health. We look at four major players: Haleon, which separated from GSK almost two years ago; Kenvue, soon to celebrate its first anniversary as a new company; Sanofi Consumer Healthcare, which is poised to split from its pharma parent; and Bayer, which has decided to buck the trend, holding on to its consumer health division. We discuss some of the advantages of becoming a standalone company, for example in leaning into a wider concept of self-care.