Risk Management Principles for Devices and Pharmaceuticals
99
Introduction
This Chapter 7 describes the International
Organization for Standardization (ISO) stan-
dards for risk management for medical devices,
ISO 14971:2019.1 A historical overview is given
on how the standard developed over time, to
show its close relation with the European direc-
tives for medical devices and the latest revision of
ISO 14971 with the European Medical Device
Regulations. Because of this close relation the
European context is described in this chapter. In
other jurisdictions this integration of ISO 14971
is less precise and thus less critical. The rela-
tion to other standards like ISO 134852 is also
explained, as well as its relationship with clinical
evaluation and benefit-risk analysis, which is
described in more detail in Chapters 11 and 15.
ISO 14971 provides a generic process for
risk management of all kinds of medical devices,
applicable to the entire lifecycle, from design
and development through decommissioning and
disposal. The standard is primarily aimed at med-
ical device manufacturers, but it can also be used
by other parties involved in the lifecycle of the
device such as suppliers. It can also be applied to
other products that are not necessarily considered
to be medical devices in all jurisdictions, but
can be subject to device regulations or similar
regulations, such as the products without an
intended medical purpose listed in Annex XVI of
the EU Medical Device Regulation (MDR).3
Risk Management History in the
Medical Device Industry
With the introduction of the European Active
Implantable Medical Devices Directive 90/385/
EEC (AIMDD),4 medical devices directive
(MDD)5 risk analysis became an essential
requirement. Risks needed to be reduced as far
as possible while accounting for the general
acknowledged state of the art and a high level
of protection of health and safety. European
standard EN 1441:19976 Medical devices—
risk analysis was developed together with the
European directives. EN 1441 provided a risk
analysis method to investigate the safety of
medical devices by identifying hazards and esti-
mating risks based on available information. The
standard was to be used in combination with the
essential requirements of the directives.
EN 1441 was taken as a starting point for
the development of ISO 14971-17 in 1998. ISO
14971-1 was intended to be the first in a series of
standards about risk management. Plans changed
and the first edition of ISO 14971 was developed
Risk Management in Medical
Devices and Artificial Intelligence
Leo Hovestadt, MSc
7
99
Introduction
This Chapter 7 describes the International
Organization for Standardization (ISO) stan-
dards for risk management for medical devices,
ISO 14971:2019.1 A historical overview is given
on how the standard developed over time, to
show its close relation with the European direc-
tives for medical devices and the latest revision of
ISO 14971 with the European Medical Device
Regulations. Because of this close relation the
European context is described in this chapter. In
other jurisdictions this integration of ISO 14971
is less precise and thus less critical. The rela-
tion to other standards like ISO 134852 is also
explained, as well as its relationship with clinical
evaluation and benefit-risk analysis, which is
described in more detail in Chapters 11 and 15.
ISO 14971 provides a generic process for
risk management of all kinds of medical devices,
applicable to the entire lifecycle, from design
and development through decommissioning and
disposal. The standard is primarily aimed at med-
ical device manufacturers, but it can also be used
by other parties involved in the lifecycle of the
device such as suppliers. It can also be applied to
other products that are not necessarily considered
to be medical devices in all jurisdictions, but
can be subject to device regulations or similar
regulations, such as the products without an
intended medical purpose listed in Annex XVI of
the EU Medical Device Regulation (MDR).3
Risk Management History in the
Medical Device Industry
With the introduction of the European Active
Implantable Medical Devices Directive 90/385/
EEC (AIMDD),4 medical devices directive
(MDD)5 risk analysis became an essential
requirement. Risks needed to be reduced as far
as possible while accounting for the general
acknowledged state of the art and a high level
of protection of health and safety. European
standard EN 1441:19976 Medical devices—
risk analysis was developed together with the
European directives. EN 1441 provided a risk
analysis method to investigate the safety of
medical devices by identifying hazards and esti-
mating risks based on available information. The
standard was to be used in combination with the
essential requirements of the directives.
EN 1441 was taken as a starting point for
the development of ISO 14971-17 in 1998. ISO
14971-1 was intended to be the first in a series of
standards about risk management. Plans changed
and the first edition of ISO 14971 was developed
Risk Management in Medical
Devices and Artificial Intelligence
Leo Hovestadt, MSc
7