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CHAPTER 27

Risk Management for Legacy Devices

Abstract
For established manufacturers, it’s likely that they have products that have been in the market for a
long time. Perhaps even before the existence of ISO 14971. These products are termed Legacy
Devices; defined as medical devices which were legally placed on the market and are still marketed
today, but for which there is insufficient objective evidence that they are in compliance with the
current version of the Standard. This chapter provides guidance on how to manage the risks of
Legacy Devices.
Keywords: Risk management; legacy device

For established manufacturers, it’s likely that they have products that have been in the
market for a long time. Perhaps even before the existence of ISO 14971. These pro-
ducts are termed Legacy Devices; defined as medical devices which were legally
placed on the market and are still marketed today, but for which there is insufficient
objective evidence that they are in compliance with the current version of the
Standard [3,7].
Since ISO 14971 is intended to be applied throughout the entire lifecycle, espe-
cially during the design phase, a retrospective application of the standard to an existing
legacy device is not particularly valuable. However, an abbreviated application of the
Standard [3,7] would be of value, particularly for postproduction risk management
and maintenance of the risk management file.
The following steps may be performed as an alternative to performing clauses 4 6
of the Standard [3,7].
1. Ensure there is a risk management process in place that is compliant with clause
3.1 of the Standard [3,7].
2. Prepare a risk management plan for the legacy device in accordance with clause
3.4 of the Standard [3], [7].
The scope of the risk management plan can be limited to: the creation of
the risk management file, performance of production and postproduction risk
management, and maintenance of the risk management file. The plan should
define the actions and responsibility for field data collection and processing. If
future versions of the device will be developed, the plan should lay out the
appropriate activities for the risk management of the new device.

Safety Risk Management for Medical Devices r 2018 Elsevier Ltd.
DOI: https://doi.org/10.1016/B978-0-12-813098-8.00027-1 All rights reserved. 209