ISO TR 24971:2013 pdf free download.Medical devices – Guidance on the application of ISo 14971.
Experience Indicates that manufacturers have difficulty with practical implementatIon of tome clauses of the risk management International Standard. ISO 14971:2007, Medical devices — Appikat ion of risk management to medical devices. This Technical Report provides guidance to assist in the development. implementation and maintenance of risk management for medical devices that aim to meet the requirements of ISO 14971. It provides guidance for specific aspects of ISO 14971 for a wide variety of medical devices. These medical devices Include active, non-active, implantable. and non-implantable medical devices and In viiro diagnostic medical devices.
This Technical Report is not intended to be an overall guidance document an the implementation of
ISO 14971 for organizations. It supplements the guidance contained in the Informative annexes of
ISO 14971 related to the following areas.
— Guidance on the role of international product safety and process standards in risk management
— Guidance on developing the policy for determining the criteria for risk acceptability
— Guidance on how the production and post-production feedback loop can work
— Guidance on the differentiation of information for safety as a risk control measure and disclosure of residual risk
— Guidance on the evaluation of nverall residual risk
This Technical Report provides someapproaches that an organization can use to implement and maintain some aspects of a risk management system that conforms to ISO 14971, Alternative approaches can be used if these satisfy the requirements of ISO 14971.
When judging the applicability of the guidance in this Technical Report, one should consider the nature of the medical device(s) to which ii will apply, the risks associated with the use oIthese medical devices, and the applicable regulatory requirements.
This Technical Report provides guidance In addressing specific areas of Iso 14971 when implementing risk managemenL
The guidance is intended to assist manufacturers and other users of the standard to:
— understand the role of International product safety and process standards In risk management:
develop the policy for determining the criteria for risk acceptability;
— incorporate productton and post-production leedback loop into risk management:
— differentiate between “Information for safely” and disclosure of residual risk; and
— evaluate overall residual risk.
2 The role of International product safety and process standards In risk management
International product safety and process standards play a significant role In risk management as described by Iso 14971. In principle, these standards are dcvclopcd using a type of risk management that can include identifying hazards and hazardous situations, estimating risks, evaluating risks, and specifying risk control measures. More information on a process for developing medical device standards using a type of risk management can be found in documents such as ISO/IEC Guide 51 and ISO/IEC Guide 63. International product safety and process standards are developed by experts in the field and represent the generally accepted state olthe art (see D.4 of ISO 14971:2007).
These standards can have an important role in risk management. When performing risk management. the manufacturer first needs to consider the medical device being designed, Its intended use and the hazards/hazardous situations related to it. Manufacturers can, if they choose, identify standard(s) that contain specific requirements that help manage the risks related to those hazards/hazardous situations.
For medical devices that satisfy the requIrements and compliance criteria of these standards, the residual risks related to those hazards/hazardous situations can be considered acceptable unless there Is oblective evidence to the contrary. Some potential sources of objective evidence to the contrary can include reports of adverse events, product recalls and complaints. The requirements of International Standards, such as engineering or analytical processes, specific output limits, warning statements, or design specifications, can be considered risk control measures established by the standards writers that are Intended to address the risks of specific hazardous situations that have been identified and evaluated as needing risk control.
In many cases, the standards writers have taken on and completed elements of risk management and provided manufacturers with answers in the form of design requirements and test methods for establishing conformity. When performing risk management activities, manufacturers can take advantage of the work of the standards writers and need not repeat the analyses leading to the requirements of the standard. International standards, therefore, provide valuable information on risk acceptability that has been validated during a worldwide evaluation process, Including multiple rounds of review, comment, and voting.
According to ISO 10993-1, expert assessors should determine If the available information/data are sufficient to determine ilihe overall residual risk associated with biological hazards is acceptable. This conclusion is documented in the Biological Evaluation Report, which becomes an element of the risk management file.
3 Developing the policy for determining the criteria for risk acceptability
According to 3.2 of ISO 14971:2007. top management is required to define and document the policy for determining the criteria for risk acceptability. This policy Is intended to ensure that criteria:
a) are based upon applicable national or regional regulations:
b) are based upon relevant International Standards;
c) take into account available information such as the generally accepted state of the art and known stakehalder concerns.
NOTE Other relevant Information can also be included.
The policy could cover the entire range of a manufacturer’s medical devices or it can take different forms depending on whether the medical devices are similar to each other, or whether the differences between groups of medical devices are significant.
When developing or maintaining the policy the following should he taken into consideration:
— The applicable regulatory requirements in the regions where the medical device is to be marketed,
— The relevant International Standards for the particular medical device or an intended use of the medical device that can help identify principles for setting the criteria for risk acceptability (see 22).
— Information on the state of the art can be obtained from review of the literature and other information on similar medical devices the manufacturer has marketed, as well as those from competing companies.
— The validated and comprehensive concerns from the main stakeholders, Some potential sources of information on the patient and clinician perspective can include news media, social media, patient forums, as well as input from internal departments with expert knowledge of stakeholder concerns such as the clinical department.
The manufacturer should provide guidelines for developing the actual criteria for risk acceptability to be used in the risk management plan for the particular medical device being considered (see 3.4 of
The review of the suitability of the risk management process at planned intervals, as required by 3.2 of ISO 14971:2007, can demonstrate the appropriateness of previously used criteria for risk acceptability or lead to changes in the policy. Such changes can also lead to reviewing the appropriateness of previous risk acceptability decisions.
4 Production and post-production feedback loop
Typically, the initial risk assessment is based on experience with similar medical devices or applications on the market, or on assumptions when new medical devices are released to the market. Information received alter market entry is valuable for confirming or correcting assumptions and estimates (both overestimates and underestimates), or identifying omissions made during the risk analysis and risk control phases. Clause 9 of ISO 14971:2007 requires that a feedback loop Is established In the
Some examples are given below to Illustrate the residual risks associated with using the medical device and such side effects that are normally disclosed.
— irnear accelerators can be used to treat t umours. The residual risks of radiation therapy br tumours can include the possibility of erytherna or epilation.
— When patients undergo magnetic resonance Imaging (MRI), they sometimes experience anxiety due to: being in an endosed space, hearing the loud noise generated by the equipment, and needing to remain still during imaging.
6 Evaluation of overall residual risk
Alter the assessment olevery identified separate hazardous situation, the manufacturer then considers the combined impact of the Individual residual risks, and decides whether the overall residual risk meets or exceeds the crIteria for residual risk acceptability stated in the risk management plan. This step is particularly important [or complex medical systems and for medical devices with a large number of individual risks. The evaluation can be used for making a case that the product is safe.
Clause 7 of Iso 14971:2007 requires that the overall residual risk be evaluated against the criteria stated in the risk management plan, However, the determination of overall residual risk Is a difficult and challenging task that cannot be achieved simply by numerically adding all individual risks. It is even uncertain Iladding risks Is possIble at all, because each probability of occurrence olharm is related to a different severity of that harm. This difficulty also arises for the following reasons:
— Even In the later stages of medical device development, confidence in the probability estimates can vary considerably. Some probabilities are known precisely either from history with similar medical devices or from testing. Other probabilities are only estimates and might be known very imprecisely or not at all, such as the probability of a software failure. Also it is usually not possible to combine the seventies of individual harms within the broad categories usually used In risk analysis.
— ISO 14971 does not specify that the criteria for risk acceptability for individual risks need to be the same as the criteria for overall risk acceptability. The criteria used to evaluate Individual risks are usually based on the probability of occurrence of particular seventies of harm.
P.4 and P.7 of ISO 14971:2007 lIst some possible general techniques or methods for evaluating overall residual risk along with considerations affecting their selection. Setting criteria based on the policy for determining criteria for risk acceptability is covered by ISO 14971 in general and guidance is found in Ckusc3. Both the criteria and the methods associated with them should be stated in the risk management plan. This guidance is intended to help In estahlishing such criteria and methods.
6.2 Inputs and other considerations for overall residual risk evaluation
The overall residual risk can only be assessed after all risk control measures have been Implemented and verified. This means that all identified hazardous situations have been evaluated and that all risks have been reduced to an acceptable level or have been accepted based upon a risk/benefit analysis. Some examples of Inputs and their use are presented below. These can be used as Input to overall residual risk evaluation and considerations that should be made in determining whether the overall residual risk Is acceptable.
a) The manufacturercan compare the medical device underreview tosimilarmarketed medical devices (see P.7.7 of ISO 14971:2007). In order for the manufacturer to make well considered conclusions about the overall residual risk In relation to the medical benefits olihe medical device under review, up-to.date Information on intended use and associated adverse events of similar marketed medical devices should be reviewed, as well as information from scientific literature, Including information about clinical experience. The key question is whether the medical device under review offers the same or better safety as a medical device that can be considered to have an acceptable overall residual risk.
ISO TR 24971:2013 pdf free download.Medical devices – Guidance on the application of ISo 14971.