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Chapter 11: Artificial Intelligence
Change According to Medical Device
Legislation
Most medical device regulations require a con-
formity assessment before a manufacturer can
place a device on the market. The conformity
assessment must demonstrate the regulatory
requirements are met.24 Devices can change in
terms of design and characteristics after confor-
mity assessment, but only if the manufacturer has
a quality management system to address these
changes in a timely manner with regard to reg-
ulatory compliance, including compliance with
conformity assessment procedures.25 Manufac-
turers are prohibited from suggesting uses for the
device other than those stated in the intended
use for which the conformity assessment was
carried out.26 So, what does this mean for devices
that change during use?
In the EU, notified bodies must have
documented procedures and contractual arrange-
ments in place with the manufacturer relating
to the assessment of changes to the approved
design of a device and the intended use or claims
made for the device. Manufacturers must submit
plans for such changes for prior approval. Such
changes may affect conformity with the general
safety and performance requirements or with the
conditions prescribed for the use of the product,
including changes related to limitations of the
intended purpose or conditions of use. The noti-
fied body must assess the proposed changes and
verify whether, after these changes, the design
of a device or type of a device still meets the
requirements of the regulation, must notify the
manufacturer of its decision, and must provide a
report or, as applicable, a supplementary report
to the EU technical documentation assessment
certificate containing the justified conclusions of
its assessment.27
This implies that a manufacturer can place
a device on the market that can change within a
pre-defined change envelope or tolerances for
which a conformity assessment was carried out,
provided the manufacturer respects the con-
tractual agreements with the notified body. This
approach appears possible under most medical
device legislation.
In contrast, no medical device legislation
currently exists that allows manufacturers to
place machine learning devices on the mar-
ket that are intended to change outside of the
change envelope or to suggest claims, intended
uses, or use conditions to the device for which
no conformity assessment was carried out (see
Figure 11-6). For example, the functionality of
a machine learning device placed on the market
intended to detect frontotemporal dementia
evolves during runtime to detect dementia with
Lewy Bodies or Creutzfeldt Jakob disease this is
considered a new intended purpose and requires
a new conformity assessment.
Changes outside of the change envelope or
assigning new claims or use conditions require an
update of the technical documentation, includ-
ing the clinical evaluation and a new conformity
assessment to be carried out.28 Significant changes
to the pre-determined ACP require an update of
the technical documentation, including the clini-
cal evaluation and a new conformity assessment.
Assume a natural or legal person wants to
place an existing device on the market in the
EU (1) by changing its intended purpose or (2)
by modifying it in a way that compliance with
the applicable requirements may be affected. In
that case, that person shall assume the obliga-
tions incumbent on manufacturers, except if they
change the device, without changing its intended
purpose, to adapt it for an individual patient.
Then manufacturer obligations do not ensue,
but a Member State may still require the person
to register as a manufacturer of custom-made
devices. This implies that a person can adapt a
machine learning bionic eye to restore a patient’s
eyesight if the eye is intended for that purpose,
even if this involves a modification in such a way
that compliance may be affected.
In the EU, a health institution can (1)
change the intended purpose or (2) modify a
device in such a way that compliance with the
applicable requirements are affected so that it
can be used on multiple patients, but only if
Chapter 11: Artificial Intelligence
Change According to Medical Device
Legislation
Most medical device regulations require a con-
formity assessment before a manufacturer can
place a device on the market. The conformity
assessment must demonstrate the regulatory
requirements are met.24 Devices can change in
terms of design and characteristics after confor-
mity assessment, but only if the manufacturer has
a quality management system to address these
changes in a timely manner with regard to reg-
ulatory compliance, including compliance with
conformity assessment procedures.25 Manufac-
turers are prohibited from suggesting uses for the
device other than those stated in the intended
use for which the conformity assessment was
carried out.26 So, what does this mean for devices
that change during use?
In the EU, notified bodies must have
documented procedures and contractual arrange-
ments in place with the manufacturer relating
to the assessment of changes to the approved
design of a device and the intended use or claims
made for the device. Manufacturers must submit
plans for such changes for prior approval. Such
changes may affect conformity with the general
safety and performance requirements or with the
conditions prescribed for the use of the product,
including changes related to limitations of the
intended purpose or conditions of use. The noti-
fied body must assess the proposed changes and
verify whether, after these changes, the design
of a device or type of a device still meets the
requirements of the regulation, must notify the
manufacturer of its decision, and must provide a
report or, as applicable, a supplementary report
to the EU technical documentation assessment
certificate containing the justified conclusions of
its assessment.27
This implies that a manufacturer can place
a device on the market that can change within a
pre-defined change envelope or tolerances for
which a conformity assessment was carried out,
provided the manufacturer respects the con-
tractual agreements with the notified body. This
approach appears possible under most medical
device legislation.
In contrast, no medical device legislation
currently exists that allows manufacturers to
place machine learning devices on the mar-
ket that are intended to change outside of the
change envelope or to suggest claims, intended
uses, or use conditions to the device for which
no conformity assessment was carried out (see
Figure 11-6). For example, the functionality of
a machine learning device placed on the market
intended to detect frontotemporal dementia
evolves during runtime to detect dementia with
Lewy Bodies or Creutzfeldt Jakob disease this is
considered a new intended purpose and requires
a new conformity assessment.
Changes outside of the change envelope or
assigning new claims or use conditions require an
update of the technical documentation, includ-
ing the clinical evaluation and a new conformity
assessment to be carried out.28 Significant changes
to the pre-determined ACP require an update of
the technical documentation, including the clini-
cal evaluation and a new conformity assessment.
Assume a natural or legal person wants to
place an existing device on the market in the
EU (1) by changing its intended purpose or (2)
by modifying it in a way that compliance with
the applicable requirements may be affected. In
that case, that person shall assume the obliga-
tions incumbent on manufacturers, except if they
change the device, without changing its intended
purpose, to adapt it for an individual patient.
Then manufacturer obligations do not ensue,
but a Member State may still require the person
to register as a manufacturer of custom-made
devices. This implies that a person can adapt a
machine learning bionic eye to restore a patient’s
eyesight if the eye is intended for that purpose,
even if this involves a modification in such a way
that compliance may be affected.
In the EU, a health institution can (1)
change the intended purpose or (2) modify a
device in such a way that compliance with the
applicable requirements are affected so that it
can be used on multiple patients, but only if