is being presented by Dr. Joachim Wilke, Director, Regulatory Affairs & Policy, Europe, with Medtronic and airs on Thursday, March 15th, 2012. For more details or to register, please visit our site at www.fxconferences.com
In July 2011 the EU Commission published the recast Restriction of Hazardous Substances (RoHS) Directive 2011/65/EU which will replace the original RoHS Directive 2002/95/EC. The new Directive has to be transposed into the national laws of EU Member States by January 2, 2013. In contrast to the original version, its scope will include Medical Devices effective July 22, 2014, and therefore RoHS compliance will become one of the major quality and regulatory activities of medical device manufacturers during the upcoming months.
This audio conference presentation summarizes the requirements of Directive 2011/65/EU with particular attention to its scope and exemptions. Our speaker also explains the responsibilities of manufacturers and distributors. According to the Directive, RoHS compliance must be demonstrated by a Declaration of Conformity and by affixing a CE mark to the device. As a matter of fact, the Medical Device Directive 93/42/EEC CE mark, which includes the Notified Body identification number, will cover RoHS compliance in the future as well. Accordingly, this presentation covers questions related to Notified Body Quality Management auditing including Technical File and Declaration of Conformity review.
