Authors: Erika Huffman, MSBME, RAC
The ISO 14971 standard for medical devices released in 2007 provided manufacturers with a framework to assess and manage risks associated with the use of their medical devices. The European version of this standard—EN ISO 14971—contains the same normative text as the ISO standard, plus additional appendices (Annex Z) that clarify compliance gaps between the ISO standard and the Essential Requirements of the European medical device directives (93/42/EEC on Medical Devices, 90/385/EEC on Active Implantable Medical Devices, and 98/79/EC on In Vitro Diagnostic Devices). The recently released EN ISO 14971:2012 standard provides additional clarity on the applicability and alignment of ISO 14971:2007 clauses with the requirements of the EU medical device directives. One key difference between the EU requirements and the ISO standard is that manufacturers must reduce risk “as far as possible” (EEC Directive) as compared to “as low as reasonably practicable” (ISO standard). Device companies should be aware that the EEC directives must be met and that all risks must be reduced as far as possible, without room for economic considerations, and that all risks together must be taken into account and balanced against the overall benefits of the device if the device is to be marketed in the European Union. It is recommended that companies discuss the implications of the new EN ISO 14971: 2012 standard with their Notified Body.