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EU Clarifies Implementation of 2007/47/EC
The European Commission has clarified several issues which have arisen relating to the implementation of Council Directive 2007/47/EC - the revision to the active implantable medical devices directive (Directive 90/385/EEC) and the medical devices directive (Directive 93/42/EEC).
The clarification addresses the end of transition and when the mandatory phase for this directive comes into force - 21 March 2010. In addition, the clarification addresses responsibilities of manufacturers - for example with respect to the drawing up of revised Declaration of Conformity - and for Notified Bodies - for example with respect to issuance of new and revised EC Certificates.
One of the most significant areas of revision has to do with software - especially software which by intent meets the criteria of a medical device, such as web applications, which will need to be CE marked as of the mandatory period.
For more information including a copy of the clarification, a copy of the directive, and or for a no-cost/obligation quotation addressing compliance and CE Marking, send an email to "info@" and "2007/47" in the subject line.