2007 Version of Risk Management Standard Harmonized to the European Medical Directives

Steve McRoberts, CSci CPhys MInstP
Global Principal Engineer - Medical, Underwriters Laboratories

EN ISO 14971:2007 is now harmonized to the European Medical Devices Directive (93/42/EEC), the Active Implantable Medical Device Directive (90/385/EEC) and In-Vitro Diagnostics Directive (98/79/EC). Until 31 March 2010 both the 2007 edition and the 2000 edition are harmonized providing a presumption of conformity to one or more essential requirements of either directive (if the standard is applied in full). After 31 March 2010 only the 2007 edition will harmonized and at that date the 2000 edition shall no longer provide a presumption of conformity. The transition period until 31 March 2010 is intended to allow manufacturer to assess the extent of the changes and implement the changes into their products and systems in order to maintain compliance with the directives. Manufacturers can learn about the full extent of the changes to the standard through various training organizations, including UL University. The change in the standard from the old to the new edition are small in terms of additions to the normative text but can have a significant impact for manufacturer's sytems, some specific changes are: (cl 3.4) requirements for risk management plan to include aspects of gathering production and production information, (cl. 6.4) process for disclosure of residual risk and (cl 9) the necessity to gather information from the device production phase (as well as post-production phases). There are also significant changes to the informative annexes of the standard.