ISO 14971:2019 – WHAT’S NEW?

Medical device manufacturers are now more responsible than ever for ensuring their products and devices offer the promised benefits and do not come with any unmanageable risks. Ordinances, laws and normative standards need to be observed when bringing medical devices into circulation, so that the devices are safe for patients, users and third parties.

ISO 14971 is one of the key standards for manufacturers of medical devices. This standard regulates risk management for medical devices. According to its specifications, effective and sustainable risk management needs to be performed to identify and resolve potential risks.

In December 2019, the third version of ISO 14971 was published and it brought with it a number of changes concerning application and new terms, for example.

Generally, it is important to note: ISO 14971:2019 is not harmonized. Changes for adjusting to the MDR may still be made in the future.

At the same time, the ISO/TR 24971 guideline was also revised; a number of annexes to the 14971:2019 edition were postponed in this report, making it more important now. However, ISO/TR 24971 is yet to be published.

New provisions and changes in ISO 14971:2019

Chapter structure

The chapter structure of ISO 14971:2019 has changed as a new Chapter 2 has been added for normative information. Here, medical device manufacturers are advised to check how and to what extent their internal company approach to the risk management process, including descriptions, need to be adjusted as a result.

Annexes

Numerous annexes (C, D, F-H and J) were moved to ISO/TR 24971, however this has not yet been published. Annex I was removed. The relationships between hazards, hazard situations and damages as well as new hazards are explained in Annex C.

Changes and additions to terminology

New terms were added, while existing definitions were adjusted, becoming more binding. For example:

Benefit/risk analysis – greater relevance of the benefit: The positive, medical influence or intended medical result that relates to the health of the patient, patient management or public health is now encompassed under the term “benefit” and thus given more focus (e.g. quicker improvement to health condition, recovery of health with fewer side effects).
State of the art – is defined as the generally recognized, technical state of processes, products and services, whereby focus is placed more on good practices and less on the prevalent modern state of technology.
Reasonably foreseeable misuse – the manufacturer describes an erroneous or unsuitable application of the medical device in a manner not intended by the manufacturer, which may however result from foreseeable human behavior (DIN EN 82079-1).

Area of application / risk management system

The area of application was revised so that terminology and principles are more precisely covered in addition to the process description. Besides the consideration of medical devices and in-vitro diagnostics, the standard now also covers software under “medical devices”.
ISO 14971:2019 links the responsibility of personnel in risk management more strongly with the explicitly named manufacturer and greater qualifications of the affected personnel in risk management are called for with “training” and “skills” (education/knowledge, training, skills and experience). An approach is outlined upon closer consideration that goes beyond the pure process definition and addresses verifiable implementation.

Moreover, for the risk management process the standard demands that the hazard situation is identified when considering potential risks in order to reduce them to an acceptable level, based on the objective criteria of risk acceptance as defined by the medical device manufacturer.
Safety-related characteristics have to be recorded and reasonably foreseeable misuse must be identified.
The “Risk Management Report” chapter was renamed to “Review of Risk Management” in order to present and document the results in the risk management report.
The topic of data and system security is firmly addressed in this standard edition, although without describing specific requirements.

Collecting and reviewing data and literature / post-market surveillance

The new standard edition pays greater attention to considerations and assessments in the phases following production and aligns them with the activities of post-market surveillance. As is already the case in the MDR, these requirements on market monitoring activities are given more weight in ISO 14971:2019. The focus of this standard aspect has moved from the mere generation of information to the specific activities of collective and assessing information as well as initiating mitigation measures. Besides the state of the art, information on similar products also needs to be gathered in this context.

The medical device manufacturer needs to establish a proactive and systematic system within their company. The information is to be assessed for possible safety relevance in order to determine whether hazards exists that were not previously recognized, whether the assessments of the probability and severity of damage are no longer reasonable and whether the original evaluations can no longer be applied as a result of other aspects.

If one of these conditions is fulfilled, the results from the current evaluation process must be incorporated into the risk management process as an input. They form the basis for the corresponding risk-reducing measures for the medical devices on the market. The implementation of risk reduction must be verifiably documented.

Risk acceptance criteria / assessment of overall residual risk

With the new standard edition, the manufacturer is now able to define other acceptance criteria for assessing individual risks than for assessing the overall residual risk. This way, acceptance criteria for individual risks can be used to evaluate whether measures are required for risk management and whether acceptance criteria for the overall residual risk can be used to decide on the distribution on a device. The standard also obliges manufacturers to describe methods for assessment and acceptance criteria for the overall residual risk in the risk management plan, in addition to defining methods and the acceptance of individual risks. While the manufacturer previously had to decide which information was relevant for the supporting documents, now the user must be expressly informed.

Quintessence:

The third version of ISO 14971 does not reinvent the activities and management of risks for medical device manufacturers. Compliance with the normative requirements is expanded and specified with a number of changes, which nonetheless involve adjustments in the risk management process. Risk management for medical devices therefore continues to be a central and important element in the medical sector.

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ISO 14971:2019 – WHAT’S NEW?

New provisions and changes in ISO 14971:2019

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