BSI supports medical device manufacturers to modernize risk management systems

18th December 2019

The newly updated standard helps medical device manufacturers to manage risk throughout the entire life cycle of a device in line with changing European regulation  

BSI, the business improvement company, releases BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices to provide organizations with terminology, principles and a process for the risk management of medical devices, including software and In Vitro Diagnostic.

Medical device manufacturers harbour a responsibility to identify and control hazards associated with devices on an international scale. This updated standard provides a framework to identify, estimate, control, evaluate and monitor the associated risks. It is applicable to all phases of the life cycle of a medical device and applies to risks including biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. It is appropriate to be used by all types and sizes of organizations dealing with the design, development, production, installation or servicing of medical equipment, devices and technology.

Rob Turpin, Head of Healthcare Standards at BSI said: “Risk management is a key process for the medical devices sector, and this new edition of the international standard expresses the requirements with greater accuracy and detail. It defines best practices for risk management across the entire life cycle of a medical device, by providing a framework for risk analysis, evaluation and control.”

This standard requires manufacturers to establish objective criteria for risk acceptability but does not specify acceptable risk levels. Risk management can be an integral part of a quality management system. However, this standard does not require the manufacturer to have a quality management system in place. This document does not apply to the use of a medical device in the context of clinical procedure or business risk management.

This is the third edition of ISO 14971 to be published. The previous edition was adopted as a European Standard in 2012 and is currently harmonized under the EU Directives for Medical Devices (93/42/EEC, 90/385/EEC and 98/79/EC). Acknowledging the delays in the harmonization process to the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), and in order not to delay the publication of the third edition of ISO 14971, international working groups (ISO/TC 210/JWG1 and CEN/CLC TC3) have decided to decouple the development of the European and international versions of this standard from the European harmonization process. This will permit the publication of both versions of the standard on the same date.  It is envisaged this edition will be re-coupled with the European harmonization process at a later date upon the completion of the respective annexes (Annex Z) covering the relationship between the standard and the MDR and IVDR (2017/745 and 2017/746).