Archive for the ‘Regulation’ Category
Tuesday, March 9th, 2010
Medical device manufacturers are required to comply with Medical Devices Directive 93/42/EEC as amended by Directive 2007/47/EC by 21 March 2010. Despite having made every effort to meet the essential requirements, companies may be surprised to learn that the classification of some of their devices may be challenged, writes René ...
Posted in Regulation, medtechinsider | Add Comment »
Monday, February 1st, 2010
SGS has extended its medical device Notified Body status to include Directive 98/79/EC for in vitro diagnostic (IVD) medical devices. The company’s initial scope of designation as an IVD Directive Notified Body includes all LIST B devices and Self-Test IVD devices. This scope will be further expanded to include all ...
Posted in Industry News, Regulation, medtechinsider | Add Comment »
Friday, January 22nd, 2010
From the Wire: Dr Jeffrey Shuren has been appointed permanent Director of FDA’s Center for Devices and Radiological Health (CDRH). He previously served as Acting Center Director after the resignation of Dan Schulz in August 2009. FDA Commissioner Margaret Hamburg appointed Shuren to the job on a permanent basis on ...
Posted in Industry News, Regulation, US Regulatory, medtechinsider | Add Comment »
