The Medical Device Directive 93/42 EEC as Amended by 2007/47 EC—Are you Ready? 

Manufacturers must be in full compliance with the changes that apply to them by March 21, 2010. 

Changes to the Directive include, but are not limited to:

• Re-Classification of some devices that impact the central circulatory system
• Record retention
• Increased emphasis on clinical data (required for all devices, regardless of EU classification)
• Software classification
• Conformity assessment options-class I manufacturers may choose Annex II
• More in depth review of technical documentation by Notified Bodies
• Usability/ergonomics per EN 62366
• Overlap with Machinery Directive 2006/42 EC

It is critical that each manufacturer review 2007/47 as well as related guidance documents to determine what changes are applicable and the impact of the changes.  Reviews should be documented and with justification for those requirements deemed not applicable.