One of the cornerstones of compliance with the European medical device directives is risk management, making the Harmonised Standard EN ISO 14971:2012, ‘Medical devices - Application of risk management to medical devices’, one of the most important documents in a compliance strategy.
 
 
EN ISO 14971 not only documents requirements for manufacturers, but also provides a comprehensive road map to compliance, laying out a systematic step-by-step approach to help in the identification of potential hazards and their associated risks, together with evaluation and mitigation of those risks.
 
 
Risk management according to EN ISO 14971 is becoming increasingly important as the latest versions of a number of ISO, IEC, CEN and CENELEC technical standards, including the ubiquitous EN IEC 60601 series, require compliance with specific clauses to be checked by means of reference to the manufacturer’s risk management file.
 
 
EN ISO 14971 not only gives requirements for risk assessment at the design stage, but also asks manufacturers to consider the ongoing risks associated with serial production, such as engineering revisions and production process changes.
 
 
With the inclusion of the need to establish 'usability' of devices under the revised Directives, the risk management file must now also address the risks of use errors. Utilising harmonised standard EN ISO/IEC 62366:2008 will provide manufacturers with the guidance needed to ensure a satisfactory Usability Engineering File is developed for inclusion in the device Technical File.
 
 
GEMAR can help you develop your medical device risk management and usability files as part of the CE marking process - contact us for further information.