The New Rules for Safety and Performance of Medical Devices in the EU

is being presented by Salma Michor, CEO and Principal Consultant, of Michor Consulting EU and airs on Thursday, May 19th, 2011. For more details, or to register please visit our site at www.fxconferences.com

In the EU rules relating to the safety and performance of medical devices were harmonized in the 1990s. The legal framework consists of three main directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/EEC regarding medical devices and Directive 98/79/EC regarding in vitro diagnostic medical devices. These three main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47/EC.

The revised MDD 93/42/EC (via 2007/47/EC) took effect in March 2010, marking the onset of more rigorous regulations in the EU. Manufacturers must comply with the new requirements for both new products and products already on the market. This audio conference provides an overview of the latest updates introduced by Directive 2007/47/EC, and what they mean for device manufacturers.