Apr 8, 2019

UK requests another Brexit deadline extension, furthering market uncertainties

EMERGO SUMMARY OF KEY POINTS: The British Prime Minister has asked to have Brexit Day...
Jan 17, 2013

German Trade Group Wants Faster Regulatory Action on NB Surveillance

The German Medical Technology Association (BVMed), Germany's largest medical device industry trade group, has urged...
Jan 16, 2013

New EU Electronic Labeling Rules for Medical Devices Coming in March 2013

This regulation outlines how Instructions for Use may be provided in electronic format to professional users for certain medical devices under the Medical Device Directive and Active Implantable Medical Device Directive.
Oct 26, 2012

Fresh Notified Body Scandal Bolsters Arguments for EU Medical Device Regulatory Reforms

A recent investigation by British journalists has brought to light questionable practices by certain European...
Oct 23, 2012

Overview of new medical device regulations in Europe

The long awaited proposed Regulations for medical devices (and active implantable medical devices) and IVDs...
Mar 13, 2012

Final Publication of e-IFU Regulations March 30th

Final publication of the European Commission’s regulations covering electronic instructions for
Feb 13, 2012

Tighter EU Regulatory Controls Proposed following PIP Controversy

European Union member states should take immediate steps to
Jan 18, 2012

European Med-Tech Trade Groups Join Forces

European medical technology association Eucomed and the European Diagnostic Manufacturers Association (EDMA) are forming a...
Nov 7, 2011

Drug and Medical Device Modernization Law Nearing Adoption in France

Two versions of a draft law amending regulations of pharmaceutical and medical technology products in...
Apr 18, 2011

BVMed Annual Report: Healthy Returns, but Stronger Regulatory Support for Innovation Needed

In its latest annual report , German medical device industry trade group BVMed (Bundesverband Medezintechnologie)...