MRA (mutual recognition agreement) agreements provide opportunities and headaches for European notified bodies
This article was originally published in Clinica
Executive Summary
European notified bodies are keen to become accredited by the US, Canada, Australia and New Zealand in the testing of medical devices. However, a serious lack of interest on the part of industry could mean that many notified bodies are on the point of making a serious business mistake - and one that exposes them to scrutiny by the US FDA.
You may also be interested in...
Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
World-First Nod For Yuhan's Lung Cancer Drug, In Korea
The leading Korean pharma firm’s oral, third-generation EGFR-TKI is approved in the country, providing a new option for patients with advanced NSCLC and increasing hopes for global approvals given an ongoing global Phase III combination trial led by partner J&J.
DePuy Synthes Gains US FDA Clearance For Velys Robot For Total Knee Surgery
DePuy Synthes expects its Velys robotic-assisted system to be cost-effective, easy-to-use and to be well-suited for use in ambulatory surgery centers.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: