Aug 31, 2015
Nouvelles réglementations en négociation pour les dispositifs médicaux et de DIV en Europe
Le 19 juin 2015, le Conseil des ministres de l'Union européenne a décidé de son...
Feb 25, 2011
EU: Broad Support for IVDD Revisions
Comments following European Union regulators’ public consultation on proposed revision to Directive 98/79/EC indicate
Feb 18, 2011
Battle Lines Drawn in Congressional Hearing on FDA Review Process
Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.
Feb 16, 2011
US Congress Wading into FDA Reform Debate
Opponents of the Food and Drug Administration’s reform efforts targeting medical device reviews have a sympathetic ear in Joe Pitts, the Republican congressman from Pennsylvania who now chairs the Hou
Jan 28, 2011
AdvaMed-sponsored Study: FDA Less Efficient than EU Regulators
A new study sponsored by the US medical device industry trade association Advanced Medical Technology...
Jan 21, 2011
European Union Regulatory Update
The European Union’s regulatory community appears to be a flurry of activity with new MEDDEV...
Dec 21, 2010
EC Report: Joint Replacement Surgeries on the Rise
A new report issued by the European Commission and the Organization for Cooperation and Economic...
Dec 15, 2010
European Court Limits Member States’ Authority over Medical Device E-Commerce
The European Court has recently ruled to limit member states’ authority to restrict medical
Dec 15, 2010
EU Unveils New Medical Device Clinical Investigation Guidelines
New medical device guidelines, MEDDEV 2.7.4 , addressing clinical investigations have been issued in the Eu
Dec 15, 2010
40-year EU Patent Impasse at an End?
The European Patent Office (EPO), the European Commission body theoretically responsible for evaluation of patent applications, appears closer than at any point in the last 40 years to achieving a mor