Medical Electrical Device (MED) companies are required to adopt IEC 60601-1 edition 3 in 2012.  The timeline to adopt to the new standard is as follows:

Europe: June 1, 2012
Canada: June 1, 2012
USA: July 1, 2013

This standard requires more in depth Risk Analysis, consistent with ISO 14971:2007 requirements covering product lifecycle in addition to re-testing the device to 60601-1 edition 3. The Risk Management Audit part of the compliance consists of full review of implementation of ISO 14971 which requires addressing all elements as required by this standard.

The following steps need to be taken to comply with 60601-1 edition 3:

• Familiarize yourself with the standard
• Revise your Risk Management File to ensure it is consistent with ISO 14979:2007
• Update your design file to cover risk management requirements
• Retest the device to IEC 60601-1 edition 3