Checklist MDR

Checklist: MDR General Safety and Performance Requirements
Chapter I: General Requirements

N
o Requirem Applicab Rationa Applicable
. ent le le Standard Evidence of Conformity
1 Devices Yes ISO 14971:2019 Intended UseRisk
shall Management
achieve the ReportClinical
performan Evaluation Report
ce
intended
by their
manufactu
rer and
shall be
designed
and
manufactu
red in such
a way that,
during
normal
conditions
of use, they
are
suitable for
their
intended
purpose.
They shall
be safe and
effective
and shall
not
compromis
e the
clinical
condition
or the
safety of
patients, or
the safety
N
and health
of users or,
where
applicable,
other
persons,
provided
that any
risks which
may be
associated
with their
use
constitute
acceptable
risks when
weighed
against the
benefits to
the patient
and are
compatible
with a high
level of
protection
of health
and safety,
taking into
account
the
generally
acknowled
ged state of
the art.
2 The Yes ISO 14971:2019 Risk Management
requireme Report
nt in this
Annex to
reduce
risks as far
as possible
means the
N
reduction
of risks as
far as
possible
without
adversely
affecting
the
benefit-
risk ratio.
3 Manufactu Yes ISO 14971:2019 SOP Risk Management
rers shall
establish,
implement,
document
and
maintain a
risk
manageme
nt system.
Risk
manageme
nt shall be
understoo
d as a
continuous
iterative
process
throughout
the entire
lifecycle of
a device,
requiring
regular
systematic
updating.
In carrying
out risk
manageme
nt
manufactu
rers shall:
N
( establish Yes ISO 14971:2019 Risk Management Plan
a and
) document
a risk
manageme
nt plan for
each
device;
( identify Yes ISO 14971:2019 Risk Table
b and
) analyze the
known and
foreseeabl
e hazards
associated
with each
device;
( estimate Yes ISO 14971:2019 Risk Table
c and
) evaluate
the risks
associated
with, and
occurring
during, the
intended
use and
during
reasonably
foreseeabl
e misuse;
( eliminate Yes ISO 14971:2019 Risk Table
d or control
) the risks
referred to
in point (c)
in
accordance
with the
requireme
nts of
N
Section 4;
( evaluate Yes ISO 14971:2019 Risk TableSOP
e the impact Integrated Software
) of Development
informatio
n from the
production
phase and,
in
particular,
from the
post-
market
surveillanc
e system,
on hazards
and the
frequency
of
occurrence
thereof, on
estimates
of their
associated
risks, as
well as on
the overall
risk,
benefit-
risk ratio
and risk
acceptabili
ty; and
( based on Yes ISO 14971:2019 Risk Table
f the
) evaluation
of the
impact of
the
informatio
n referred
to in point
N
(e), if
necessary
amend
control
measures
in line with
the
requireme
nts of
Section 4.
4 Risk Yes ISO 14971:2019 Risk Table
control
measures
adopted by
manufactu
rers for the
design and
manufactu
re of the
devices
shall
conform to
safety
principles,
taking
account of
the
generally
acknowled
ged state of
the art. To
reduce
risks,
Manufactu
rers shall
manage
risks so
that the
residual
risk
associated
with each
N
hazard as
well as the
overall
residual
risk is
judged
acceptable.
In selecting
the most
appropriat
e solutions,
manufactu
rers shall,
in the
following
order of
priority:
( eliminate Yes ISO 14971:2019 Risk Table
a or reduce
) risks as far
as possible
through
safe design
and
manufactu
re;
( where Yes ISO 14971:2019 Risk Table
b appropriat
) e, take
adequate
protection
measures,
including
alarms if
necessary,
in relation
to risks
that cannot
be
eliminated;
and
N
( provide Yes ISO 14971:2019 Risk Table
c informatio
) n for safety
(warnings/
precaution
s/contra-
indications
) and,
where
appropriat
e, training
to users.
5 In
eliminating
or
reducing
risks
related to
use error,
the
manufactu
rer shall:
( reduce as Yes IEC 62366-1:2015 + Risk TableSoftware
a far as COR1:2016 Requirements
) possible ListUsability Evaluation
the risks Report
related to
the
ergonomic
features of
the device
and the
environme
nt in which
the device
is intended
to be used
(design for
patient
safety),
and
N
( give Yes IEC 62366-1:2015 + Intended UseRisk Table
b considerati COR1:2016
) on to the
technical
knowledge,
experience,
education,
training
and use
environme
nt, where
applicable,
and the
medical
and
physical
conditions
of intended
users
(design for
lay,
profession
al, disabled
or other
users).
6 The No Software
characteris device
tics and
performan
ce of a
device
shall not
be
adversely
affected to
such a
degree that
the health
or safety of
the patient
or the user
and, where
N
applicable,
of other
persons
are
compromis
ed during
the lifetime
of the
device, as
indicated
by the
manufactu
rer, when
the device
is
subjected
to the
stresses
which can
occur
during
normal
conditions
of use and
has been
properly
maintained
in
accordance
with the
manufactu
rer’s
instruction
s.
7 Devices No Software
shall be device
designed,
manufactu
red and
packaged
in such a
way that
N
their
characteris
tics and
performan
ce during
their
intended
use are not
adversely
affected
during
transport
and
storage, for
example,
through
fluctuation
s of
temperatu
re and
humidity,
taking
account of
the
instruction
s and
informatio
n provided
by the
manufactu
rer.
8 All known Yes ISO 14971:2019 Clinical Evaluation
and Report
foreseeabl
e risks, and
any
undesirabl
e side-
effects,
shall be
minimized
and be
N
acceptable
when
weighed
against the
evaluated
benefits to
the patient
and/or
user
arising
from the
achieved
performan
ce of the
device
during
normal
conditions
of use.
9 For the No Annex
devices XVI does
referred to not
in Annex apply
XVI, the
general
safety
requireme
nts set out
in Sections
1 and 8
shall be
understoo
d to mean
that the
device,
when used
under the
conditions
and for the
purposes
intended,
does not
N
present a
risk at all
or presents
a risk that
is no more
than the
maximum
acceptable
risk
related to
the
product’s
use which
is
consistent
with a high
level of
protection
for the
safety and
health of
persons.
Chapter II: Requirements Regarding Design and Manufacture

2.1) Chemical, Physical and Biological Properties
N
0 shall be device
. designed
1 and
manufactu
red in such
a way as to
ensure that
the
characteris
tics and
performan
ce
N
requireme
nts
referred to
in Chapter
I are
fulfilled.
Particular
attention
shall be
paid to:
( the choice No Software
a of device
) materials
and
substances
used,
particularl
y as
regards
toxicity
and, where
relevant,
flammabili
ty;
( the No Software
b compatibili device
) ty between
the
materials
and
substances
used and
biological
tissues,
cells and
body
fluids,
taking
account of
the
intended
purpose of
N
the device
and, where
relevant,
absorption,
distributio
n,
metabolis
m and
excretion;
( the No Software
c compatibili device
) ty between
the
different
parts of a
device
which
consists of
more than
one
implantabl
e part;
( the impact No Software
d of device
) processes
on
material
properties;
( where No Software
e appropriat device
) e, the
results of
biophysical
or
modelling
research
the validity
of which
has been
demonstra
ted
N
beforehan
d;
( the No Software
f mechanical device
) properties
of the
materials
used,
reflecting,
where
appropriat
e, matters
such as
strength,
ductility,
fracture
resistance,
wear
resistance
and fatigue
resistance;
( surface No Software
g properties; device
) and
( the No Software
h confirmati device
) on that the
device
meets any
defined
chemical
and/or
physical
specificatio
ns.
0 shall be device
. designed,
2 manufactu
red and
packaged
N
in such a
way as to
minimize
the risk
posed by
contamina
nts and
residues to
patients,
taking
account of
the
intended
purpose of
the device,
and to the
persons
involved in
the
transport,
storage
and use of
the
devices.
Particular
attention
shall be
paid to
tissues
exposed to
those
contamina
nts and
residues
and to the
duration
and
frequency
of
exposure.
0 shall be device
N
. designed
3 and
manufactu
red in such
a way that
they can be
used safely
with the
materials
and
substances
, including
gases, with
which they
enter into
contact
during
their
intended
use; if the
devices are
intended
to
administer
medicinal
products
they shall
be
designed
and
manufactu
red in such
a way as to
be
compatible
with the
medicinal
products
concerned
in
accordance
with the
N
provisions
and
restriction
s
governing
those
medicinal
products
and that
the
performan
ce of both
the
medicinal
products
and of the
devices is
maintained
in
accordance
with their
respective
indications
and
intended
use.
2.2) Substances
N
0 shall be device
. designed
4 and
. manufactu
1 red in such
a way as to
reduce as
far as
possible
the risks
N
posed by
substances
or
particles,
including
wear
debris,
degradatio
n products
and
processing
residues,
that may
be released
from the
device.
Devices, or
those parts
thereof or
those
materials
used
therein
that:
— are No Software
invasive device
and come
into direct
contact
with the
human
body,
— No Software
(re)admini device
ster
medicines,
body
liquids or
other
substances
, including
gases,
N
to/from
the body,
or
— No Software
transport device
or store
such
medicines,
body fluids
or
substances
, including
gases, to be
(re)admini
stered to
the body,
shall only No Software
contain the device
following
substances
in a
concentrati
on that is
above 0,1
% weight
by weight
(w/w)
where
justified
pursuant
to Section
10.4.2:
( substances No Software
a which are device
) carcinogen
ic,
mutagenic
or toxic to
reproducti
on (‘CMR’),
of category
N
1A or 1B,
in
accordance
with Part 3
of Annex
VI to
Regulation
(EC) No
1272/200
8 of the
European
Parliament
and of the
Council
(1), or
( substances No Software
b having device
) endocrine-
disrupting
properties
for which
there is
scientific
evidence of
probable
serious
effects on
human
health and
which are
identified
either in
accordance
with the
procedure
set out in
Article 59
of
Regulation
(EC) No
1907/200
6 of the
N
European
Parliament
and of the
Council (2)
or, once a
delegated
act has
been
adopted by
the
Commissio
n pursuant
to the first
subparagra
ph of
Article
5(3) of
Regulation
(EU) No
528/2012
of the
European
Parliament
and the
Council
(3), in
accordance
with the
criteria
that are
relevant to
human
health
amongst
the criteria
established
therein.
1 Justificatio No Software
0 n device
. regarding
4 the
. presence
N
2 of CMR
and/or
endocrine-
disrupting
substances
: The
justificatio
n for the
presence
of such
substances
shall be
based
upon:
( an analysis No Software
a and device
) estimation
of
potential
patient or
user
exposure
to the
substance;
( an analysis No Software
b of possible device
) alternative
substances
, materials
or designs,
including,
where
available,
informatio
n about
independe
nt
research,
peer-
reviewed
studies,
scientific
N
opinions
from
relevant
scientific
committee
s and an
analysis of
the
availability
of such
alternative
s;
( argumenta No Software
c tion as to device
) why
possible
substance
and/ or
material
substitutes
, if
available,
or design
changes, if
feasible,
are
inappropri
ate in
relation to
maintainin
g the
functionali
ty,
performan
ce and the
benefit-
risk ratios
of the
product;
including
taking into
account if
N
the
intended
use of such
devices
includes
treatment
of children
or
treatment
of
pregnant
or
breastfeedi
ng women
or
treatment
of other
patient
groups
considered
particularl
y
vulnerable
to such
substances
and/or
materials;
and
( where No Software
d applicable device
) and
available,
the latest
relevant
scientific
committee
guidelines
in
accordance
with
Sections
10.4.3. and
N
10.4.4.
1 Guidelines No Software
0 on device
. phthalates:
4 For the
. purposes
3 of Section
10.4., the
Commissio
n shall, as
soon as
possible
and by 26
May 2018,
provide
the
relevant
scientific
committee
with a
mandate to
prepare
guidelines
that shall
be ready
before 26
May 2020.
The
mandate
for the
committee
shall
encompass
at least a
benefit-
risk
assessmen
t of the
presence
of
phthalates
which
N
belong to
either of
the groups
of
substances
referred to
in points
(a) and (b)
of Section
10.4.1. The
benefit-
risk
assessmen
t shall take
into
account
the
intended
purpose
and
context of
the use of
the device,
as well as
any
available
alternative
substances
and
alternative
materials,
designs or
medical
treatments
. When
deemed
appropriat
e on the
basis of the
latest
scientific
evidence,
N
but at least
every five
years, the
guidelines
shall be
updated.
1 Guidelines No Software
0 on other device
. CMR and
4 endocrine-
. disrupting
4 substances
:Subseque
ntly, the
Commissio
n shall
mandate
the
relevant
scientific
committee
to prepare
guidelines
as referred
to in
Section
10.4.3. also
for other
substances
referred to
in points
(a) and (b)
of Section
10.4.1.,
where
appropriat
e.
1 Labelling: No Software
0 Where device
. devices,
4 parts
. thereof or
N
5 materials
are used
therein as
referred to
in Section
10.4.1.
contain
substances
referred to
in points
(a) or (b)
of Section
10.4.1. in a
concentrati
on above
0,1 %
weight by
weight
(w/w), the
presence
of those
substances
shall be
labelled on
the device
itself
and/or on
the
packaging
for each
unit or,
where
appropriat
e, on the
sales
packaging,
with the
list of such
substances
. If the
intended
use of such
N
devices
includes
treatment
of children
or
treatment
of
pregnant
or
breastfeedi
ng women
or
treatment
of other
patient
groups
considered
particularl
y
vulnerable
to such
substances
and/or
materials,
informatio
n on
residual
risks for
those
patient
groups
and, if
applicable,
on
appropriat
e
precaution
ary
measures
shall be
given in
the
N
instruction
s for use.
0 shall be device
. designed
5 and
manufactu
red in such
a way as to
reduce as
far as
possible
the risks
posed by
the
unintentio
nal ingress
of
substances
into the
device
taking into
account
the device
and the
nature of
the
environme
nt in which
it is
intended
to be used.
0 shall be device
. designed
6 and
manufactu
red in such
a way as to
reduce as
far as
possible
N
the risks
linked to
the size
and the
properties
of particles
which are
or can be
released
into the
patient’s or
user’s
body,
unless they
come into
contact
with intact
skin only.
Special
attention
shall be
given to
nanomater
ials.
2.3) Infection and Microbiological Contamination

N
1 and their device
. manufactu
1 ring
processes
shall be
designed
in such a
way as to
eliminate
or to
reduce as
far as
N
possible
the risk of
infection to
patients,
users and,
where
applicable,
other
persons.
The design
shall:
( reduce as No Software
a far as device
) possible
and
appropriat
e the risks
from
unintende
d cuts and
pricks,
such as
needle
stick
injuries,
( allow easy No Software
b and safe device
) handling,
( reduce as No Software
c far as device
) possible
any
microbial
leakage
from the
device
and/or
microbial
exposure
during use,
and
N
( prevent No Software
d microbial device
) contaminat
ion of the
device or
its content
such as
specimens
or fluids.
1 Where No Software
1 necessary device
. devices
2 shall be
designed
to facilitate
their safe
cleaning,
disinfectio
n, and/or
re-
sterilizatio
n.
1 labelled as device
. having a
3 specific
microbial
state shall
be
designed,
manufactu
red and
packaged
to ensure
that they
remain in
that state
when
placed on
the market
and remain
so under
N
the
transport
and
storage
conditions
specified
by the
manufactu
rer.
1 delivered device
. in a sterile
4 state shall
be
designed,
manufactu
red and
packaged
in
accordance
with
appropriat
e
procedures
, to ensure
that they
are sterile
when
placed on
the market
and that,
unless the
packaging
which is
intended
to
maintain
their
sterile
condition
is
damaged,
N
they
remain
sterile,
under the
transport
and
storage
conditions
specified
by the
manufactu
rer, until
that
packaging
is opened
at the
point of
use. It shall
be ensured
that the
integrity of
that
packaging
is clearly
evident to
the final
user.
1 labelled as device
. sterile
5 shall be
processed,
manufactu
red,
packaged
and,
sterilized
by means
of
appropriat
e, validated
methods.
N
1 intended device
. to be
6 sterilised
shall be
manufactu
red and
packaged
in
appropriat
e and
controlled
conditions
and
facilities.
1 Packaging No Software
1 systems device
. for non-
7 sterile
devices
shall
maintain
the
integrity
and
cleanliness
of the
product
and, where
the devices
are to be
sterilised
prior to
use,
minimise
the risk of
microbial
contaminat
ion; the
packaging
system
shall be
N
suitable
taking
account of
the method
of
sterilisatio
n indicated
by the
manufactu
rer.
1 The No Software
1 labelling of device
. the device
8 shall
distinguish
between
identical or
similar
devices
placed on
the market
in both a
sterile and
a non-
sterile
condition
additional
to the
symbol
used to
indicate
that
devices are
sterile.
2 incorporati device
ng a
substance
considered
to be a
medicinal
product
N
and
devices
that are
composed
of
substances
or of
combinatio
ns of
substances
that are
absorbed
by or
locally
dispersed
in the
human
body.
1 In the case No Software
2 of devices device
. referred to
1 in the first
subparagra
ph of
Article
1(8), the
quality,
safety and
usefulness
of the
substance
which, if
used
separately,
would be
considered
to be a
medicinal
product
within the
meaning of
point (2) of
N
Article 1 of
Directive
2001/83/E
C, shall be
verified by
analogy
with the
methods
specified in
Annex I to
Directive
2001/83/E
C, as
required
by the
applicable
conformity
assessmen
t
procedure
under this
Regulation.
2 that are device
. composed
2 of
substances
or of
combinatio
ns of
substances
that are
intended
to be
introduced
into the
human
body, and
that are
absorbed
by or
locally
N
dispersed
in the
human
body shall
comply,
where
applicable
and in a
manner
limited to
the aspects
not
covered by
this
Regulation,
with the
relevant
requireme
nts laid
down in
Annex I to
Directive
2001/83/E
C for the
evaluation
of
absorption,
distributio
n,
metabolis
m,
excretion,
local
tolerance,
toxicity,
interaction
with other
devices,
medicinal
products
or other
substances
N
and
potential
for adverse
reactions,
as required
by the
applicable
conformity
assessmen
t
procedure
under this
Regulation.
2.4) Devices Incorporating Materials of Biological Origin

N Requirem Applicab Rationa Applicable Evidence of
o. ent le le Standard Conformity
13 For No Softwar
.1 devices e device
manufactu
red
utilizing
derivatives
of tissues
or cells of
human
origin
which are
non-viable
or are
rendered
non-viable
covered by
this
Regulation
in
accordanc
e with
point (g) of
Article
1(6), the
following
shall
apply:
(a donation, No Softwar
) procureme e device
nt and
testing of
the tissues
and cells
shall be
done in
accordanc
e with
Directive
2004/23/
EC;
(b processing No Softwar
) , e device
preservati
on and any
other
handling of
those
tissues and
cells or
their
derivatives
shall be
carried out
so as to
provide
safety for
patients,
users and,
where
applicable,
other
persons. In
particular,
safety with
regard to
viruses
and other
transmissi
ble agents
shall be
addressed
by
appropriat
e methods
of sourcing
and by
implement
ation of
validated
methods of
eliminatio
n or
inactivatio
n in the
course of
the
manufactu
ring
process;
(c the No Softwar
) traceabilit e device
y system
for those
devices
shall be
compleme
ntary and
compatible
with the
traceabilit
y and data
protection
requireme
nts laid
down in
Directive
2004/23/
EC and in
Directive
2002/98/
EC.
13 For No Softwar
.2 devices e device
manufactu
red
utilizing
tissues or
cells of
animal
origin, or
their
derivatives
, which are
non-viable
or
rendered
non-viable
the
following
shall
apply:
(a where No Softwar
) feasible e device
taking into
account
the animal
species,
tissues and
cells of
animal
origin, or
their
derivatives
, shall
originate
from
animals
that have
been
subjected
to
veterinary
controls
that are
adapted to
the
intended
use of the
tissues.
Informatio
n on the
geographic
al origin of
the
animals
shall be
retained
by
manufactu
rers;
(b sourcing, No Softwar
) processing e device
,
preservati
on, testing
and
handling of
tissues,
cells and
substances
of animal
origin, or
their
derivatives
, shall be
carried out
so as to
provide
safety for
patients,
users and,
where
applicable,
other
persons. In
particular
safety with
regard to
viruses
and other
transmissi
ble agents
shall be
addressed
by
implement
ation of
validated
methods of
eliminatio
n or viral
inactivatio
n in the
course of
the
manufactu
ring
process,
except
when the
use of such
methods
would lead
to
unaccepta
ble
degradatio
n
compromi
sing the
clinical
benefit of
the device;
(c in the case No Softwar
) of devices e device
manufactu
red
utilizing
tissues or
cells of
animal
origin, or
their
derivatives
, as
referred to
in
Regulation
(EU) No
722/2012
the
particular
requireme
nts laid
down in
that
Regulation
shall apply.
13 For No Softwar
.3 devices e device
manufactu
red
utilizing
non-viable
biological
substances
other than
those
referred to
in Sections
13.1 and
13.2, the
processing
,
preservati
on, testing
and
handling of
those
substances
shall be
carried out
so as to
provide
safety for
patients,
users and,
where
applicable,
other
persons,
including
in the
waste
disposal
chain. In
particular,
safety with
regard to
viruses
and other
transmissi
ble agents
shall be
addressed
by
appropriat
e methods
of sourcing
and by
implement
ation of
validated
methods of
eliminatio
n or
inactivatio
n in the
course of
the
manufactu
ring
process.
2.5) Construction of Devices and Interaction with their Environment
14 If the No Softwar
.1 device is e device
intended
for use in
combinati
on with
other
devices or
equipment
the whole
combinati
on,
including
the
connection
system
shall be
safe and
shall not
impair the
specified
performan
ce of the
devices.
Any
restriction
s on use
applying to
such
combinati
ons shall
be
indicated
on the
label
and/or in
the
instruction
s for use.
Connectio
ns which
the user
has to
handle,
such as
fluid, gas
transfer,
electrical
or
mechanica
l coupling,
shall be
designed
and
constructe
d in such a
way as to
minimise
all possible
risks, such
as
misconnec
tion.
14 Devices No Softwar
.2 shall be e device
designed
and
manufactu
red in such
a way as to
remove or
reduce as
far as
possible:
(a the risk of No Softwar
) injury, in e device
connection
with their
physical
features,
including
the
volume/pr
essure
ratio,
dimension
al and
where
appropriat
e
ergonomic
features;
(b risks Yes Softwar IEC 62366-1:2015 + Risk TableUsability
) connected e device COR1:2016 Evaluation Report
with
reasonably
foreseeabl
e external
influences
or
environme
ntal
conditions,
such as
magnetic
fields,
external
electrical
and
electromag
netic
effects,
electrostat
ic
discharge,
radiation
associated
with
diagnostic
or
therapeuti
c
procedure
s,
pressure,
humidity,
temperatu
re,
variations
in
pressure
and
acceleratio
n or radio
signal
interferenc
es;
(c the risks No Softwar
) associated e device
with the
use of the
device
when it
comes into
contact
with
materials,
liquids,
and
substances
, including
gases, to
which it is
exposed
during
normal
conditions
of use;
(d the risks Yes ISO Risk Table
) associated 14971:2
with the 919
possible
negative
interaction
between
software
and the IT
environme
nt within
which it
operates
and
interacts;
(e the risks of No Softwar
) accidental e device
ingress of
substances
into the
device;
(f) the risks of No Softwar
reciprocal e device
interferenc
e with
other
devices
normally
used in the
investigati
ons or for
the
treatment
given; and
(g risks No Softwar
) arising e device
where
maintenan
ce or
calibration
are not
possible
(as with
implants),
from
ageing of
materials
used or
loss of
accuracy
of any
measuring
or control
mechanis
m.
designed
and
manufactu
red in such
a way as to
minimize
the risks of
fire or
explosion
during
normal use
and in
single fault
condition.
Particular
attention
shall be
paid to
devices the
intended
use of
which
includes
exposure
to or use in
association
with
flammable
or
explosive
substances
or
substances
which
could
cause
combustio
n.
14 Devices Yes IEC 62304:2006 / Software Development
.4 shall be AMD1:2015 and Maintenance Plan
designed
and
manufactu
red in such
a way that
adjustmen
t,
calibration
, and
maintenan
ce can be
done
safely and
effectively.
14 Devices Yes IEC 62304:2006 / Software Requirements
.5 that are AMD1:2015 List
intended
to be
operated
together
with other
devices or
products
shall be
designed
and
manufactu
red in such
a way that
the
interopera
bility and
compatibil
ity are
reliable
and safe.
14 Any No No
.6 measurem measuri
ent, ng
monitoring function
or display
scale shall
be
designed
and
manufactu
red in line
with
ergonomic
principles,
taking
account of
the
intended
purpose,
users and
the
environme
ntal
conditions
in which
the devices
are
intended
to be used.
designed
and
manufactu
red in such
a way as to
facilitate
their safe
disposal
and the
safe
disposal of
related
waste
substances
by the
user,
patient or
other
person. To
that end,
manufactu
rers shall
identify
and test
procedure
s and
measures
as a result
of which
their
devices
can be
safely
disposed
after use.
Such
procedure
s shall be
described
in the
instruction
s for use.
2.6) Devices with a Diagnostic or Measurement Function

N
1 Diagnostic No No
5 devices measuri
. and ng
1 devices function
with a
measuring
function,
shall be
designed
and
manufactu
red in such
a way as to
provide
sufficient
accuracy,
N
precision
and
stability
for their
intended
purpose,
based on
appropriat
e scientific
and
technical
methods.
The limits
of accuracy
shall be
indicated
by the
manufactu
rer.
1 The No No
5 measurem measuri
. ents made ng
2 by devices function
with a
measuring
function
shall be
expressed
in legal
units
conformin
g to the
provisions
of Council
Directive
80/181/E
EC (4).
2.7) Protection Against Radiation
N
1 General
6
.
1
( Devices No No
a shall be radiatio
) designed, n
manufactu
red and
packaged
in such a
way that
exposure
of patients,
users and
other
persons to
radiation is
reduced as
far as
possible,
and in a
manner
that is
compatible
with the
intended
purpose,
whilst not
restricting
the
application
of
appropriat
e specified
levels for
therapeuti
c and
diagnostic
purposes.
( The No No
N
b operating radiatio
) instruction n
s for
devices
emitting
hazardous
or
potentially
hazardous
radiation
shall
contain
detailed
informatio
n as to the
nature of
the
emitted
radiation,
the means
of
protecting
the patient
and the
user, and
on ways of
avoiding
misuse and
of reducing
the risks
inherent to
installation
as far as
possible
and
appropriat
e.
Informatio
n
regarding
the
acceptance
N
and
performan
ce testing,
the
acceptance
criteria,
and the
maintenan
ce
procedure
shall also
be
specified.
1 Intended
6 radiation
.
2
( Where No No
a devices are radiatio
) designed n
to emit
hazardous,
or
potentially
hazardous,
levels of
ionizing
and/or
non-
ionizing
radiation
necessary
for a
specific
medical
purpose
the benefit
of which is
considered
to
outweigh
the risks
N
inherent to
the
emission, it
shall be
possible
for the
user to
control the
emissions.
Such
devices
shall be
designed
and
manufactu
red to
ensure
reproducib
ility of
relevant
variable
parameter
s within an
acceptable
tolerance.
( Where No No
b devices are radiatio
) intended n
to emit
hazardous,
or
potentially
hazardous,
ionizing
and/or
non-
ionizing
radiation,
they shall
be fitted,
where
possible,
N
with visual
displays
and/or
audible
warnings
of such
emissions.
1 Devices No No
6 shall be radiatio
. designed n
3 and
manufactu
red in such
a way that
exposure
of patients,
users and
other
persons to
the
emission of
unintende
d, stray or
scattered
radiation is
reduced as
far as
possible.
Where
possible
and
appropriat
e, methods
shall be
selected
which
reduce the
exposure
to
radiation
of patients,
users and
N
other
persons
who may
be affected.
1 Ionizing
6 radiation
.
4
( Devices No No
a intended radiatio
) to emit n
ionizing
radiation
shall be
designed
and
manufactu
red taking
into
account
the
requireme
nts of the
Directive
2013/59/E
uratom
laying
down basic
safety
standards
for
protection
against the
dangers
arising
from
exposure
to ionizing
radiation.
( Devices No No
b intended radiatio
N
) to emit n
ionizing
radiation
shall be
designed
and
manufactu
red in such
a way as to
ensure
that, where
possible,
taking into
account
the
intended
use, the
quantity,
geometry
and quality
of the
radiation
emitted
can be
varied and
controlled,
and, if
possible,
monitored
during
treatment.
( Devices No No
c emitting radiatio
) ionizing n
radiation
intended
for
diagnostic
radiology
shall be
designed
and
N
manufactu
red in such
a way as to
achieve an
image
and/or
output
quality
that are
appropriat
e to the
intended
medical
purpose
whilst
minimizing
radiation
exposure
of the
patient and
user.
( Devices No No
d that emit radiatio
) ionizing n
radiation
and are
intended
for
therapeuti
c radiology
shall be
designed
and
manufactu
red in such
a way as to
enable
reliable
monitoring
and
control of
the
N
delivered
dose, the
beam type,
energy
and, where
appropriat
e, the
quality of
radiation.
2.8) Devices that Incorporate Electronic Programmable Systems and Softwares that are
Devices Themselves
N
1 Devices Yes IEC 62304:2006 / Intended UseSOP
7 that AMD1:2015 Integrated Software
. incorporat DevelopmentSOP
1 e Change Management
electronic
programm
able
systems,
including
software,
or
software
that are
devices in
themselves
, shall be
designed
to ensure
repeatabili
ty,
reliability
and
performan
ce in line
with their
intended
use. In the
N
event of a
single fault
condition,
appropriat
e means
shall be
adopted to
eliminate
or reduce
as far as
possible
consequen
t risks or
impairmen
t of
performan
ce.
1 For devices Yes IEC 62304:2006 / Software Development
7 that AMD1:2015 and Maintenance Plan
. incorporat
2 e software
or for
software
that are
devices in
themselves
, the
software
shall be
developed
and
manufactu
red in
accordance
with the
state of the
art taking
into
account
the
principles
of
N
developme
nt life
cycle, risk
manageme
nt,
including
informatio
n security,
verificatio
n and
validation.
1 Software Yes IEC 62304:2006 / SOP Integrated Software
7 referred to AMD1:2015 DevelopmentSoftware
. in this Requirements List
3 Section
that is
intended
to be used
in
combinatio
n with
mobile
computing
platforms
shall be
designed
and
manufactu
red taking
into
account
the specific
features of
the mobile
platform
(e.g. size
and
contrast
ratio of the
screen)
and the
external
N
factors
related to
their use
(varying
environme
nt as
regards
level of
light or
noise).
1 Manufactu Yes IEC 62304:2006 / User ManualSoftware
7 rers shall AMD1:2015 Requirements List
. set out
4 minimum
requireme
nts
concerning
hardware,
IT
networks
characteris
tics and IT
security
measures,
including
protection
against
unauthoriz
ed access,
necessary
to run the
software
as
intended.
2.9) Active Devices and Devices Connected to Them

N
1 For non- Yes ISO 14971:2019 Risk Table
8 implantabl
. e active
N
1 devices, in
the event
of a single
fault
condition,
appropriat
e means
shall be
adopted to
eliminate
or reduce
as far as
possible
consequen
t risks.
1 Devices No Safety
8 where the does not
. safety of depend
2 the patient on
depends power
on an supply
internal
power
supply
shall be
equipped
with a
means of
determinin
g the state
of the
power
supply and
an
appropriat
e warning
or
indication
for when
the
capacity of
the power
N
supply
becomes
critical. If
necessary,
such
warning or
indication
shall be
given prior
to the
power
supply
becoming
critical.
1 Devices No Safety
8 where the does not
. safety of depend
3 the patient on
depends power
on an supply
external
power
supply
shall
include an
alarm
system to
signal any
power
failure.
1 Devices No No
8 intended monitori
. to monitor ng of
4 one or clinical
more paramet
clinical ers
parameter
s of a
patient
shall be
equipped
with
N
appropriat
e alarm
systems to
alert the
user of
situations
which
could lead
to death or
severe
deteriorati
on of the
patient’s
state of
health.
8 shall be device
. designed
5 and
manufactu
red in such
a way as to
reduce as
far as
possible
the risks of
creating
electromag
netic
interferenc
e which
could
impair the
operation
of the
device in
question or
other
devices or
equipment
in the
intended
N
environme
nt.
8 shall be device
. designed
6 and
manufactu
red in such
a way as to
provide a
level of
intrinsic
immunity
to
electromag
netic
interferenc
e such that
is adequate
to enable
them to
operate as
intended.
8 shall be device
. designed
7 and
manufactu
red in such
a way as to
avoid, as
far as
possible,
the risk of
accidental
electric
shocks to
the patient,
user or any
other
person,
both
N
during
normal use
of the
device and
in the
event of a
single fault
condition
in the
device,
provided
the device
is installed
and
maintained
as
indicated
by the
manufactu
rer.
1 Devices Yes ISO 14971:2019 Technical and
8 shall be Organizational
. designed MeasuresSoftware
8 and Requirements List
manufactu
red in such
a way as to
protect, as
far as
possible,
against
unauthoriz
ed access
that could
hamper
the device
from
functioning
as
intended.
2.10) Particular requirements for active implantable devices
N
1 Active No Software
9 implantabl device
. e devices
1 shall be
designed
and
manufactu
red in such
a way as to
remove or
minimize
as far as
possible:
( risks No Software
a connected device
) with the
use of
energy
sources
with
particular
reference,
where
electricity
is used, to
insulation,
leakage
currents
and
overheatin
g of the
devices,
( risks No Software
b connected device
) with
medical
treatment,
in
particular
those
resulting
N
from the
use of
defibrillato
rs or high-
frequency
surgical
equipment,
and
( risks which No Software
c may arise device
) where
maintenan
ce and
calibration
are
impossible,
including:
—
excessive
increase of
leakage
currents,—
ageing of
the
materials
used, —
excess heat
generated
by the
device, —
decreased
accuracy of
any
measuring
or control
mechanis
m.
9 implantabl device
. e devices
2 shall be
designed
N
and
manufactu
red in such
a way as to
ensure —
if
applicable,
the
compatibili
ty of the
devices
with the
substances
they are
intended
to
administer,
and — the
reliability
of the
source of
energy.
9 implantabl device
. e devices
3 and, if
appropriat
e, their
component
parts shall
be
identifiable
to allow
any
necessary
measure to
be taken
following
the
discovery
of a
potential
N
risk in
connection
with the
devices or
their
component
parts.
9 implantabl device
. e devices
4 shall bear a
code by
which they
and their
manufactu
rer can be
unequivoc
ally
identified
(particularl
y with
regard to
the type of
device and
its year of
manufactu
re); it shall
be possible
to read this
code, if
necessary,
without
the need
for a
surgical
operation.
2.11) Protection Against Mechanical and Thermal Risks

N
N
0 shall be device
. designed
1 and
manufactu
red in such
a way as to
protect
patients
and users
against
mechanical
risks
connected
with, for
example,
resistance
to
movement,
instability
and
moving
parts.
0 shall be device
. designed
2 and
manufactu
red in such
a way as to
reduce to
the lowest
possible
level the
risks
arising
from
vibration
generated
by the
devices,
taking
account of
N
technical
progress
and of the
means
available
for limiting
vibrations,
particularl
y at source,
unless the
vibrations
are part of
the
specified
performan
ce.
0 shall be device
. designed
3 and
manufactu
red in such
a way as to
reduce to
the lowest
possible
level the
risks
arising
from the
noise
emitted,
taking
account of
technical
progress
and of the
means
available
to reduce
noise,
particularl
N
y at source,
unless the
noise
emitted is
part of the
specified
performan
ce.
2 Terminals No Software
0 and device
. connectors
4 to the
electricity,
gas or
hydraulic
and
pneumatic
energy
supplies
which the
user or
other
person has
to handle,
shall be
designed
and
constructe
d in such a
way as to
minimise
all possible
risks.
2 Errors No Software
0 likely to be device
. made
5 when
fitting or
refitting
certain
parts
which
N
could be a
source of
risk shall
be made
impossible
by the
design and
constructio
n of such
parts or,
failing this,
by
informatio
n given on
the parts
themselves
and/or
their
housings.
The same
informatio
n shall be
given on
moving
parts
and/or
their
housings
where the
direction
of
movement
needs to be
known in
order to
avoid risk.
2 Accessible No Software
0 parts of device
. devices
6 (excluding
the parts
or areas
N
intended
to supply
heat or
reach
given
temperatu
res) and
their
surroundin
gs shall not
attain
potentially
dangerous
temperatu
res under
normal
conditions
of use.
2.12) Protection against the risks posed to the patient or user by devices supplying energy or
substances
N
2 Devices for No Software
1 supplying device
. the patient
1 with
energy or
substances
shall be
designed
and
constructe
d in such a
way that
the
amount to
be
delivered
can be set
and
N
maintained
accurately
enough to
ensure the
safety of
the patient
and of the
user.
1 shall be device
. fitted with
2 the means
of
preventing
and/or
indicating
any
inadequaci
es in the
amount of
energy
delivered
or
substances
delivered
which
could pose
a danger.
Devices
shall
incorporat
e suitable
means to
prevent, as
far as
possible,
the
accidental
release of
dangerous
levels of
energy or
N
substances
from an
energy
and/or
substance
source.
2 The No Software
1 function of device
. the
3 controls
and
indicators
shall be
clearly
specified
on the
devices.
Where a
device
bears
instruction
s required
for its
operation
or
indicates
operating
or
adjustment
parameter
s by means
of a visual
system,
such
informatio
n shall be
understan
dable to
the user
and, as
appropriat
e, the
N
patient.
2.13) Protection against the risks by medical devices intended by manufacturers for use by lay
persons
N
2 Devices for Yes IEC 62366-1:2015 + Intended UseUser
2 use by lay AC:2015 ManualUsability
. persons Evaluation Report
1 shall be
designed
and
manufactu
red in such
a way that
they
perform
appropriat
ely for
their
intended
purpose
taking into
account
the skills
and the
means
available
to lay
persons
and the
influence
resulting
from
variation
that can be
reasonably
anticipated
in the lay
person’s
technique
N
and
environme
nt. The
informatio
n and
instruction
s provided
by the
manufactu
rer shall be
easy for
the lay
person to
understan
d and
apply.
2 Devices for
2 use by lay
. persons
2 shall be
designed
and
manufactu
red in such
a way as
to:
— ensure Yes IEC 62366-1:2015 + Usability Evaluation
that the AC:2015 Report(Record of User
device can Training)
be used
safely and
accurately
by the
intended
user at all
stages of
the
procedure,
if
necessary
after
appropriat
N
e training
and/or
informatio
n,
— reduce, No Software
as far as device
possible
and
appropriat
e, the risk
from
unintende
d cuts and
pricks such
as needle
stick
injuries,
and
— reduce IEC 62366-1:2015 + Usability Evaluation
as far as AC:2015 Report
possible
the risk of
error by
the
intended
user in the
handling of
the device
and, if
applicable,
in the
interpretat
ion of the
results.
2 Devices for
2 use by lay
. persons
3 shall,
where
appropriat
e, include a
N
procedure
by which
the lay
person:
— can Yes IEC 62366-1:2015 + Stakeholder
verify that, AC:2015 RequirementsUsability
at the time Evaluation Report
of use, the
device will
perform as
intended
by the
manufactu
rer, and
— if Yes IEC 62366-1:2015 + Stakeholder
applicable, AC:2015 RequirementsUsability
is warned Evaluation Report
if the
device has
failed to
provide a
valid
result.
Chapter III: Requirements Regarding the Information Supplied with the Device
3.1) Label and Instructions for Use
N
2 Each
3 device
. shall be
1 accompani
ed by the
informatio
n needed
to identify
the device
and its
manufactu
N
rer, and by
any safety
and
performan
ce
informatio
n relevant
to the user,
or any
other
person, as
appropriat
e. Such
informatio
n may
appear on
the device
itself, on
the
packaging
or in the
instruction
s for use,
and shall, if
the
manufactu
rer has a
website, be
made
available
and kept
up to date
on the
website,
taking into
account
the
following:
( The Yes IEC 62304:2006 / User Manual
a medium, AMD1:2015
) format,
content,
N
legibility,
and
location of
the label
and
instruction
s for use
shall be
appropriat
e to the
particular
device, its
intended
purpose
and the
technical
knowledge,
experience,
education
or training
of the
intended
user(s). In
particular,
instruction
s for use
shall be
written in
terms
readily
understoo
d by the
intended
user and,
where
appropriat
e,
supplemen
ted with
drawings
and
diagrams.
N
( The Yes IEC 62304:2006 / Software Requirements
b informatio AMD1:2015 ListSOP Certification and
) n required Product Registration
on the
label shall
be
provided
on the
device
itself. If
this is not
practicable
or
appropriat
e, some or
all of the
informatio
n may
appear on
the
packaging
for each
unit,
and/or on
the
packaging
of multiple
devices.
( Labels Yes IEC 62304:2006 / Software Requirements
c shall be AMD1:2015 ListSOP Certification and
) provided Product Registration
in a
human-
readable
format and
may be
supplemen
ted by
machine-
readable
informatio
n, such as
N
radio-
frequency
identificati
on (‘RFID’)
or bar
codes.
( Instruction Yes IEC 62304:2006 / User Manual, Software
d s for use AMD1:2015,IEC Requirements List
) shall be 62366-1:2015 +
provided AC:2015
together
with
devices. By
way of
exception,
instruction
s for use
shall not
be
required
for class I
and class
IIa devices
if such
devices can
be used
safely
without
any such
instruction
s and
unless
otherwise
provided
for
elsewhere
in this
Section.
( Where Yes
e multiple
) devices are
supplied to
N
a single
user
and/or
location, a
single copy
of the
instruction
s for use
may be
provided if
so agreed
by the
purchaser
who in any
case may
request
further
copies to
be
provided
free of
charge.
( Instruction Yes IEC 62304:2006 / User Manual
f s for use AMD1:2015,IEC
) may be 62366-1:2015 +
provided AC:2015
to the user
in non-
paper
format
(e.g. electr
onic) to the
extent, and
only under
the
conditions,
set out in
Regulation
(EU) No
207/2012
or in any
subsequen
N
t
implement
ing rules
adopted
pursuant
to this
Regulation.
( Residual Yes IEC 62304:2006 / User Manual
g risks which AMD1:2015,IEC
) are 62366-1:2015 +
required to AC:2015
be
communic
ated to the
user
and/or
other
person
shall be
included as
limitations,
contra-
indications
,
precaution
s or
warnings
in the
informatio
n supplied
by the
manufactu
rer.
( Where Yes ISO 15223-1:2017 User Manual
h appropriat
) e, the
informatio
n supplied
by the
manufactu
rer shall
take the
N
form of
internation
ally
recognized
symbols.
Any
symbol or
identificati
on colour
used shall
conform to
the
harmonise
d
standards
or CS. In
areas for
which no
harmonise
d
standards
or CS exist,
the
symbols
and
colours
shall be
described
in the
documenta
tion
supplied
with the
device.
2 The label
3 shall bear
. all of the
2 following
particulars
:
( the name Yes User Manual
a or trade
N
) name of
the device;
( the details Yes User Manual
b strictly
) necessary
for a user
to identify
the device,
the
contents of
the
packaging
and, where
it is not
obvious for
the user,
the
intended
purpose of
the device;
( the name, Yes User Manual
c registered
) trade name
or
registered
trade mark
of the
manufactu
rer and the
address of
its
registered
place of
business;
( if the No Based in
d manufactu EU
) rer has its
registered
place of
business
outside the
N
Union, the
name of
the
authorized
representa
tive and
address of
the
registered
place of
business of
the
authorized
representa
tive;
( where No Software
e applicable, device
) an
indication
that the
device
contains or
incorporat
es: — a
medicinal
substance,
including a
human
blood or
plasma
derivative,
or —
tissues or
cells, or
their
derivatives
, of human
origin, or
— tissues
or cells of
animal
origin, or
N
their
derivatives
, as
referred to
in
Regulation
(EU) No
722/2012;
( where No Section
f applicable, is not
) informatio applicab
n labelled le
in
accordance
with
Section
10.4.5.;
( the lot No No batch
g number or producti
) the serial on
number of
the device
preceded
by the
words LOT
NUMBER
or SERIAL
NUMBER
or an
equivalent
symbol, as
appropriat
e;
( the UDI Yes IEC 62304:2006 / User ManualSOP
h carrier AMD1:2015,IEC Certification and
) referred to 62366-1:2015 + Product Registration
in Article AC:2015
27(4) and
Part C of
Annex VII;
(i an No Software
N
) unambiguo device
us
indication
of the time
limit for
using or
implanting
the device
safely,
expressed
at least in
terms of
year and
month,
where this
is relevant;
(j where Yes
) there is no
indication
of the date
until when
it may be
used
safely, the
date of
manufactu
re. This
date of
manufactu
re may be
included as
part of the
lot number
or serial
number,
provided
the date is
clearly
identifiable
;
( an No Software
k indication device
N
) of any
special
storage
and/or
handling
condition
that
applies;
(l if the No Software
) device is device
supplied
sterile, an
indication
of its
sterile
state and
the
sterilisatio
n method;
( warnings No Not
m or necessar
) precaution y based
s to be on risk
taken that file
need to be
brought to
the
immediate
attention
of the user
of the
device, and
to any
other
person.
This
informatio
n may be
kept to a
minimum
in which
case more
N
detailed
informatio
n shall
appear in
the
instruction
s for use,
taking into
account
the
intended
users;
( if the No No
n device is single
) intended use
for single device
use, an
indication
of that fact.
A
manufactu
rer’s
indication
of single
use shall
be
consistent
across the
Union;
( if the No No
o device is a single
) single-use use
device that device
has been
reprocesse
d, an
indication
of that fact,
the
number of
reprocessi
ng cycles
N
already
performed,
and any
limitation
as regards
the
number of
reprocessi
ng cycles;
( if the No Not
p device is custom-
) custom- made
made, the
words
‘custom-
made
device’;
( an Yes
q indication
) that the
device is a
medical
device. If
the device
is intended
for clinical
investigati
on only,
the words
‘exclusivel
y for
clinical
investigati
on’;
( in the case No Software
r of devices device
) that are
composed
of
substances
or of
N
combinatio
ns of
substances
that are
intended
to be
introduced
into the
human
body via a
body
orifice or
applied to
the skin
and that
are
absorbed
by or
locally
dispersed
in the
human
body, the
overall
qualitative
compositio
n of the
device and
quantitativ
e
informatio
n on the
main
constituent
or
constituent
s
responsibl
e for
achieving
the
principal
N
intended
action;
( for active No Software
s implantabl device
) e devices,
the serial
number,
and for
other
implantabl
e devices,
the serial
number or
the lot
number.
2 For
3 packaging
. which
3 maintains
the sterile
condition
of a device
(‘sterile
packaging’
), the
following
particulars
shall
appear on
the sterile
packaging:
( an No Software
a indication device
) permitting
the sterile
packaging
to be
recognized
as such,
( a No Software
b declaration device
N
) that the
device is in
a sterile
condition,
( the method No Software
c of device
) sterilizatio
n,
( the name No Software
d and device
) address of
the
manufactu
rer,
( a No Software
e description device
) of the
device,
( if the No Software
f device is device
) intended
for clinical
investigati
ons, the
words
‘exclusivel
y for
clinical
investigati
ons’,
g device is device
) custom-
made, the
words
‘custom-
made
device’,
( the month No Software
h and year of device
) manufactu
N
re,
(i an No Software
) unambiguo device
us
indication
of the time
limit for
using or
implanting
the device
safely
expressed
at least in
terms of
year and
month, and
(j an No Software
) instruction device
to check
the
instruction
s for use
for what to
do if the
sterile
packaging
is damaged
or
unintentio
nally
opened
before use.
2 The
3 instruction
. s for use
4 shall
contain all
of the
following
particulars
:
N
( the Yes IEC 62304:2006 / User Manual
a particulars AMD1:2015
) referred to
in points
(a), (c), (e),
(f), (k), (l),
(n) and (r)
of Section
23.2;
b device’s AMD1:2015
) intended
purpose
with a
clear
specificatio
n of
indications
, contra-
indications
, the
patient
target
group or
groups,
and of the
intended
users, as
appropriat
e;
( where Yes IEC 62304:2006 / User Manual
c applicable, AMD1:2015
) a
specificatio
n of the
clinical
benefits to
be
expected.
( where No Software
d applicable, device
N
) links to the
summary
of safety
and clinical
performan
ce referred
to in
Article 32;
e performan AMD1:2015
) ce
characteris
tics of the
device;
( where Yes IEC 62304:2006 / User Manual
f applicable, AMD1:2015
) informatio
n allowing
the
healthcare
profession
al to verify
if the
device is
suitable
and select
the
correspon
ding
software
and
accessories
;
( any Yes IEC 62304:2006 / User Manual
g residual AMD1:2015
) risks,
contra-
indications
and any
undesirabl
e side-
N
effects,
including
informatio
n to be
conveyed
to the
patient in
this
regard;
( specificatio Yes IEC 62304:2006 / User Manual
h ns the user AMD1:2015
) requires to
use the
device
appropriat
ely, e.g. if
the device
has a
measuring
function,
the degree
of accuracy
claimed for
it;
(i details of No Software
) any device
preparator
y
treatment
or
handling of
the device
before it is
ready for
use or
during its
use, such
as
sterilizatio
n, final
assembly,
calibration,
N
etc.,
including
the levels
of
disinfectio
n required
to ensure
patient
safety and
all
available
methods
for
achieving
those
levels of
disinfectio
n;
(j any Yes IEC 62304:2006 / User Manual
) requireme AMD1:2015
nts for
special
facilities,
or special
training, or
particular
qualificatio
ns of the
device user
and/or
other
persons;
k informatio AMD1:2015
) n needed
to verify
whether
the device
is properly
installed
and is
ready to
N
perform
safely and
as
intended
by the
manufactu
rer,
together
with,
where
relevant:
— details
of the
nature, and
frequency,
of
preventive
and
regular
maintenan
ce, and of
any
preparator
y cleaning
or
disinfectio
n, —
identificati
on of any
consumabl
e
component
s and how
to replace
them,—
informatio
n on any
necessary
calibration
to ensure
that the
device
N
operates
properly
and safely
during its
intended
lifetime,
and —
methods
for
eliminating
the risks
encountere
d by
persons
involved in
installing,
calibrating
or
servicing
devices;
(l if the No Software
) device is device
supplied
sterile,
instruction
s in the
event of
the sterile
packaging
being
damaged
or
unintentio
nally
opened
before use;
m device is device
) supplied
non-sterile
with the
intention
N
that it is
sterilized
before use,
the
appropriat
e
instruction
s for
sterilizatio
n;
n device is device
) reusable,
informatio
n on the
appropriat
e
processes
for
allowing
reuse,
including
cleaning,
disinfectio
n,
packaging
and, where
appropriat
e, the
validated
method of
re-
sterilizatio
n
appropriat
e to the
Member
State or
Member
States in
which the
device has
N
been
placed on
the market.
Informatio
n shall be
provided
to identify
when the
device
should no
longer be
reused,
e.g. signs of
material
degradatio
n or the
maximum
number of
allowable
reuses;
( an No No
o indication, restricti
) if ons on
appropriat reuse
e, that a
device can
be reused
only if it is
reconditio
ned under
the
responsibil
ity of the
manufactu
rer to
comply
with the
general
safety and
performan
ce
requireme
N
nts;
( if the No No
p device single-
) bears an use
indication device
that it is
for single
use,
informatio
n on
known
characteris
tics and
technical
factors
known to
the
manufactu
rer that
could pose
a risk if the
device
were to be
re-used.
This
informatio
n shall be
based on a
specific
section of
the
manufactu
rer’s risk
manageme
nt
documenta
tion, where
such
characteris
tics and
technical
factors
N
shall be
addressed
in detail. If
in
accordance
with point
(d) of
Section
23.1. no
instruction
s for use
are
required,
this
informatio
n shall be
made
available
to the user
upon
request;
( for devices Yes IEC 62304:2006 / User Manual
q intended AMD1:2015
) for use
together
with other
devices
and/or
general
purpose
equipment
:—
informatio
n to
identify
such
devices or
equipment,
in order to
obtain a
safe
combinatio
N
n, and/or
—
informatio
n on any
known
restriction
s to
combinatio
ns of
devices
and
equipment
;
( if the
r device
) emits
radiation
for medical
purposes:
— detailed No Software
informatio device
n as to the
nature,
type and
where
appropriat
e, the
intensity
and
distributio
n of the
emitted
radiation,
— the No Software
means of device
protecting
the patient,
user, or
other
person
from
N
unintende
d radiation
during use
of the
device;
( informatio Yes IEC 62304:2006 / User Manual
s n that AMD1:2015
) allows the
user
and/or
patient to
be
informed
of any
warnings,
precaution
s, contra-
indications
, measures
to be taken
and
limitations
of use
regarding
the device.
That
informatio
n shall,
where
relevant,
allow the
user to
brief the
patient
about any
warnings,
precaution
s, contra-
indications
, measures
to be taken
and
N
limitations
of use
regarding
the device.
The
informatio
n shall
cover,
where
appropriat
e:
— Yes IEC 62304:2006 / User Manual
warnings, AMD1:2015
precaution
s and/or
measures
to be taken
in the
event of
malfunctio
n of the
device or
changes in
its
performan
ce that
may affect
safety,
warnings, AMD1:2015
precaution
s and/or
measures
to be taken
as regards
the
exposure
to
reasonably
foreseeabl
e external
influences
N
or
environme
ntal
conditions,
such as
magnetic
fields,
external
electrical
and
electromag
netic
effects,
electrostati
c
discharge,
radiation
associated
with
diagnostic
or
therapeuti
c
procedures
, pressure,
humidity,
or
temperatu
re,
warnings, AMD1:2015
precaution
s and/or
measures
to be taken
as regards
the risks of
interferenc
e posed by
the
reasonably
foreseeabl
N
e presence
of the
device
during
specific
diagnostic
investigati
ons,
evaluation
s, or
therapeuti
c
treatment
or other
procedures
such as
electromag
netic
interferenc
e emitted
by the
device
affecting
other
equipment,
— if the Yes IEC 62304:2006 / User Manual
device is AMD1:2015
intended
to
administer
medicinal
products,
tissues or
cells of
human or
animal
origin, or
their
derivatives
, or
biological
substances
N
, any
limitations
or
incompatib
ility in the
choice of
substances
to be
delivered,
warnings, AMD1:2015
precaution
s and/or
limitations
related to
the
medicinal
substance
or
biological
material
that is
incorporat
ed into the
device as
an integral
part of the
device; and
precaution AMD1:2015
s related to
materials
incorporat
ed into the
device that
contain or
consist of
CMR
substances
or
endocrine-
disrupting
N
substances
, or that
could
result in
sensitisatio
n or an
allergic
reaction by
the patient
or user;
t of devices device
) that are
composed
of
substances
or of
combinatio
ns of
substances
that are
intended
to be
introduced
into the
human
body and
that are
absorbed
by or
locally
dispersed
in the
human
body,
warnings
and
precaution
s, where
appropriat
e, related
to the
N
general
profile of
interaction
of the
device and
its
products of
metabolis
m with
other
devices,
medicinal
products
and other
substances
as well as
contra-
indications
,
undesirabl
e side-
effects and
risks
relating to
overdose;
u of device
) implantabl
e devices,
the overall
qualitative
and
quantitativ
e
informatio
n on the
materials
and
substances
to which
patients
can be
N
exposed;
( warnings No Not
v or required
) precaution based on
s to be risk file
taken in
order to
facilitate
the safe
disposal of
the device,
its
accessories
and the
consumabl
es used
with it, if
any. This
informatio
n shall
cover,
where
appropriat
e:
— No Software
infection device
or
microbial
hazards
such as
explants,
needles or
surgical
equipment
contaminat
ed with
potentially
infectious
substances
of human
origin, and
N
— physical No Software
hazards device
such as
from
sharps.
If in No IFU exist
accordance
with the
point (d) of
Section
23.1 no
instruction
s for use
are
required,
this
informatio
n shall be
made
available
to the user
upon
request;
w intended AMD1:2015
) for use by
lay
persons,
the
circumstan
ces in
which the
user
should
consult a
healthcare
profession
al;
( for the No Clinical
x devices benefit
) covered by exists
N
this
Regulation
pursuant
to Article
1(2),
informatio
n
regarding
the
absence of
a clinical
benefit and
the risks
related to
use of the
device;
( date of Yes IEC 62304:2006 / User Manual
y issue of the AMD1:2015
) instruction
s for use
or, if they
have been
revised,
date of
issue and
identifier
of the
latest
revision of
the
instruction
s for use;
( a notice to Yes IEC 62304:2006 / User Manual
z the user AMD1:2015
) and/or
patient
that any
serious
incident
that has
occurred in
relation to
N
the device
should be
reported to
the
manufactu
rer and the
competent
authority
of the
Member
State in
which the
user
and/or
patient is
established
;
( informatio No Software
a n to be device
a supplied to
) the patient
with an
implanted
device in
accordance
with
Article 18;
a that AMD1:2015
b incorporat
) e
electronic
programm
able
systems,
including
software,
or
software
that are
devices in
themselves
N
, minimum
requireme
nts
concerning
hardware,
IT
networks
characteris
tics and IT
security
measures,
including
protection
against
unauthoriz
ed access,
necessary
to run the
software
as
intended.
Annex II: Technical Documentation

The technical documentation and, if applicable, the summary thereof to be drawn up by the
manufacturer shall be presented in a clear, organized, readily searchable and unambiguous
manner and shall include in particular the elements listed in this Annex.
4.1.1) Device Description and Specification

N
( product or Yes IEC 62304:2006 / Intended Use
a trade name AMD1:2015
) and a
general
description
of the
device
including
its
intended
N
purpose
and
intended
users;
( the Basic Yes IEC 62304:2006 / UDI LabelSOP
b UDI-DI as AMD1:2015 Certification and
) referred to Product Registration
in Part C of
Annex VI
assigned
by the
manufactu
rer to the
device in
question,
as soon as
identificati
on of this
device
becomes
based on a
UDI
system, or
otherwise
a clear
identificati
on by
means of
product
code,
catalogue
number or
other
unambiguo
us
reference
allowing
traceability
;
( the Yes IEC 62304:2006 / Intended Use
c intended AMD1:2015
) patient
N
population
and
medical
conditions
to be
diagnosed,
treated
and/or
monitored
and other
considerati
ons such as
patient
selection
criteria,
indications
, contra-
indications
, warnings;
( principles Yes IEC 62304:2006 / Intended Use
d of AMD1:2015
) operation
of the
device and
its mode of
action,
scientificall
y
demonstra
ted if
necessary;
( the Yes IEC 62304:2006 / Medical Device
e rationale AMD1:2015 Classification
) for the
qualificatio
n of the
product as
a device;
( the risk Yes IEC 62304:2006 / Medical Device
f class of the AMD1:2015 Classification
) device and
N
the
justificatio
n for the
classificati
on rule(s)
applied in
accordance
with Annex
VIII;
( an Yes IEC 62304:2006 / Intended Use
g explanatio AMD1:2015
) n of any
novel
features;
( a No No
h description device
) of the accessor
accessories ies
for a
device,
other
devices
and other
products
that are
not
devices,
which are
intended
to be used
in
combinatio
n with it;
(i a Yes IEC 62304:2006 / Medical Devices List
) description AMD1:2015
or
complete
list of the
various
configurati
ons/varian
N
ts of the
device that
are
intended
to be made
available
on the
market;
(j a general Yes IEC 62304:2006 / Software Development
) description AMD1:2015 and Maintenance
of the key PlanSoftware
functional Requirements List
elements,
e.g. its
parts/com
ponents
(including
software if
appropriat
e), its
formulatio
n, its
compositio
n, its
functionali
ty and,
where
relevant,
its
qualitative
and
quantitativ
e
compositio
n. Where
appropriat
e, this shall
include
labelled
pictorial
representa
tions
N
(e.g. diagra
ms,
photograp
hs, and
drawings),
clearly
indicating
key
parts/com
ponents,
including
sufficient
explanatio
n to
understan
d the
drawings
and
diagrams;
( a No Software
k description device
) of the raw
materials
incorporat
ed into key
functional
elements
and those
making
either
direct
contact
with the
human
body or
indirect
contact
with the
body, e.g.,
during
extracorpo
real
N
circulation
of body
fluids;
(l technical Yes IEC 62304:2006 / Software Requirements
) specificatio AMD1:2015 ListMarketing Material
ns, such as
features,
dimension
s and
performan
ce
attributes,
of the
device and
any
variants/c
onfiguratio
ns and
accessories
that would
typically
appear in
the
product
specificatio
n made
available
to the user,
for
example in
brochures,
catalogues
and similar
publication
s.
4.1.2) References to Previous and Similar Generations of the Device

N
( an Yes ISO 13485:2016 Medical Devices List
a overview
N
) of the
previous
generation
or
generation
s of the
device
produced
by the
manufactu
rer, where
such
devices
exist;
( an Yes ISO 13485:2016 Medical Devices
b overview ListClinical Evaluation
) of Report
identified
similar
devices
available
on the
Union or
internation
al markets,
where
such
devices
exist.
4.2) Information to be Supplied by the Manufacturer

N
A complete
set of
( — the label Yes ISO 13485:2016,IEC UDI LabelUser Manual
a or labels 62304:2006 /
) on the AMD1:2015
device and
on its
N
packaging,
such as
single unit
packaging,
sales
packaging,
transport
packaging
in case of
specific
manageme
nt
conditions,
in the
languages
accepted in
the
Member
States
where the
device is
envisaged
to be sold;
and
( — the Yes IEC 62304:2006 / User Manual
b instruction AMD1:2015
) s for use in
the
languages
accepted in
the
Member
States
where the
device is
envisaged
to be sold.
4.3) Design and Manufacturing Information
N
( informatio Yes IEC 62304:2006 / Software Development
a n to allow AMD1:2015 and Maintenance Plan
) the design
stages
applied to
the device
to be
understoo
d;
( complete Yes ISO 13485:2016,IEC SOP Integrated Software
b informatio 62304:2006 / DevelopmentSoftware
) n and AMD1:2015 Requirements
specificatio ListSystem Test Report
ns,
including
the
manufactu
ring
processes
and their
validation,
their
adjuvants,
the
continuous
monitoring
and the
final
product
testing.
Data shall
be fully
included in
the
technical
documenta
tion;
( identificati Yes ISO 13485:2016,IEC Quality Management
c on of all 62304:2006 / ManualList of Qualified
) sites, AMD1:2015 Suppliers
including
N
suppliers
and sub-
contractor
s, where
design and
manufactu
ring
activities
are
performed.
4.4) General Safety and Performance Requirements

N
The Yes MDR General Safety and
documenta Performance
tion shall Requirements Checklist
contain
informatio
n for the
demonstra
tion of
conformity
with the
general
safety and
performan
ce
requireme
nts set out
in Annex I
that are
applicable
to the
device
taking into
account its
intended
purpose,
and shall
include a
N
justificatio
n,
validation
and
verificatio
n of the
solutions
adopted to
meet those
requireme
nts. The
demonstra
tion of
conformity
shall
include:
( the general Yes MDR General Safety and
a safety and Performance
) performan Requirements Checklist
ce
requireme
nts that
apply to
the device
and an
explanatio
n as to why
others do
not apply;
( the method Yes MDR General Safety and
b or methods Performance
) used to Requirements Checklist
demonstra
te
conformity
with each
applicable
general
safety and
performan
ce
requireme
N
nt;
( the Yes MDR General Safety and
c harmonize Performance
) d Requirements Checklist
standards,
CS or other
solutions
applied;
and
( the precise Yes MDR General Safety and
d identity of Performance
) the Requirements Checklist
controlled
documents
offering
evidence of
conformity
with each
harmonize
d standard,
CS or other
method
applied to
demonstra
te
conformity
with the
general
safety and
performan
ce
requireme
nts. The
informatio
n referred
to under
this point
shall
incorporat
e a cross-
reference
to the
N
location of
such
evidence
within the
full
technical
documenta
tion and, if
applicable,
the
summary
technical
documenta
tion.
4.5) Benefit-Risk-Analysis and Risk Management

N
The
documenta
tion shall
contain
informatio
n on:
( the Yes ISO 13485:2016 Clinical Evaluation
a benefit- Report
) risk
analysis
referred to
in Sections
1 and 8 of
Annex I,
and
( the Yes ISO 13485:2016,ISO Risk TableRisk
b solutions 14971:2019 Management Report
) adopted
and the
results of
the risk
manageme
N
nt referred
to in
Section 3
of Annex I.
4.6) Product Verification and Validation

The documentation shall contain the results and critical analyses of all verifications and
validation tests and/or studies undertaken to demonstrate conformity of the device with
the requirements of this Regulation and in particular the applicable general safety and
performance requirements.
4.6.1) Pre-Clinical and Clinical Data

N
( results of Yes ISO 13485:2016 Clinical Evaluation
a tests, such Report
) as
engineerin
g,
laboratory,
simulated
use and
animal
tests, and
evaluation
of
published
literature
applicable
to the
device,
taking into
account its
intended
purpose, or
to similar
devices,
regarding
the pre-
clinical
safety of
N
the device
and its
conformity
with the
specificatio
ns;
( detailed
b informatio
) n
regarding
test design,
complete
test or
study
protocols,
methods of
data
analysis, in
addition to
data
summaries
and test
conclusion
s regarding
in
particular:
— the No Software
biocompati device
bility of the
device
including
the
identificati
on of all
materials
in direct or
indirect
contact
with the
patient or
user;
N
— No Software
physical, device
chemical
and
microbiolo
gical
characteriz
ation;
— No Software
electrical device
safety and
electromag
netic
compatibili
ty;
— Yes IEC 62304:2006 / Software Requirements
software AMD1:2015 ListSystem Test
verificatio ReportUsability
n and Evaluation Report
validation
(describing
the
software
design and
developme
nt process
and
evidence of
the
validation
of the
software,
as used in
the
finished
device.
This
informatio
n shall
typically
include the
summary
N
results of
all
verificatio
n,
validation
and testing
performed
both in-
house and
in a
simulated
or actual
user
environme
nt prior to
final
release. It
shall also
address all
of the
different
hardware
configurati
ons and,
where
applicable,
operating
systems
identified
in the
informatio
n supplied
by the
manufactu
rer);
— No Software
stability, device
including
shelf life;
and
— Yes ISO 13485:2016,ISO Risk Management
performan 14971:219,IEC ReportClinical
N
ce and 62304:2006 / Evaluation Report
safety. AMD1:2015
Where No Software
applicable, device
conformity
with the
provisions
of
Directive
2004/10/E
C of the
European
Parliament
and of the
Council (1)
shall be
demonstra
ted. Where
no new
testing has
been
undertake
n, the
documenta
tion shall
incorporat
ea
rationale
for that
decision.
An
example of
such a
rationale
would be
that
biocompati
bility
testing on
identical
materials
was
N
conducted
when
those
materials
were
incorporat
ed in a
previous
version of
the device
that has
been
legally
placed on
the market
or put into
service;
( the clinical Yes ISO 13485:2016 Clinical Evaluation
c evaluation PlanClinical Evaluation
) report and Report
its updates
and the
clinical
evaluation
plan
referred to
in Article
61(12) and
Part A of
Annex XIV;
( the PMCF Yes ISO 13485:2016 Post-Market Clinical
d plan and Follow-Up Plan and
) PMCF Report
evaluation
report
referred to
in Part B of
Annex XIV
or a
justificatio
n why a
PMCF is
N
not
applicable.
4.6.2) Additional Information Required in Specific Cases

N
( Where a No Software
a device device
) incorporat
es, as an
integral
part, a
substance
which, if
used
separately,
may be
considered
to be a
medicinal
product
within the
meaning of
point 2 of
Article 1 of
Directive
2001/83/E
C,
including a
medicinal
product
derived
from
human
blood or
human
plasma, as
referred to
in the first
subparagra
ph of
N
Article
1(8), a
statement
indicating
this fact. In
this case,
the
documenta
tion shall
identify
the source
of that
substance
and
contain the
data of the
tests
conducted
to assess
its safety,
quality and
usefulness,
taking
account of
the
intended
purpose of
the device.
( Where a No Software
b device is device
) manufactu
red
utilising
tissues or
cells of
human or
animal
origin, or
their
derivatives
, and is
covered by
N
this
Regulation
in
accordance
with points
(f) and (g)
of Article
1(6, and
where a
device
incorporat
es, as an
integral
part,
tissues or
cells of
human
origin or
their
derivatives
that have
an action
ancillary to
that of the
device and
is covered
by this
Regulation
in
accordance
with the
first
subparagra
ph of
Article
1(10), a
statement
indicating
this fact. In
such a
case, the
documenta
N
tion shall
identify all
materials
of human
or animal
origin used
and
provide
detailed
informatio
n
concerning
the
conformity
with
Sections
13.1. or
13.2.,
respectivel
y, of Annex
I.
( In the case No Software
c of devices device
) that are
composed
of
substances
or
combinatio
ns of
substances
that are
intended
to be
introduced
into the
human
body and
that are
absorbed
by or
locally
N
dispersed
in the
human
body,
detailed
informatio
n,
including
test design,
complete
test or
study
protocols,
methods of
data
analysis,
and data
summaries
and test
conclusion
s,
regarding
studies in
relation to:
— No Software
absorption, device
distributio
n,
metabolis
m and
excretion;
— possible No Software
interaction device
s of those
substances
, or of their
products of
metabolis
m in the
human
body, with
other
N
devices,
medicinal
products
or other
substances
,
considerin
g the target
population,
and its
associated
medical
conditions;
— local No Software
tolerance; device
and
— toxicity, No Software
including device
single-dose
toxicity,
repeat-
dose
toxicity,
genotoxicit
y,
carcinogen
icity and
reproducti
ve and
developme
ntal
toxicity, as
applicable
depending
on the
level and
nature of
exposure
to the
device.
In the No Software
N
absence of device
such
studies, a
justificatio
n shall be
provided.
d of devices device
) containing
CMR or
endocrine-
disrupting
substances
referred to
in Section
10.4.1 of
Annex I,
the
justificatio
n referred
to in
Section
10.4.2 of
that Annex.
e of devices device
) placed on
the market
in a sterile
or defined
microbiolo
gical
condition,
a
description
of the
environme
ntal
conditions
for the
relevant
manufactu
N
ring steps.
In the case
of devices
placed on
the market
in a sterile
condition,
a
description
of the
methods
used,
including
the
validation
reports,
with
respect to
packaging,
sterilizatio
n and
maintenan
ce of
sterility.
The
validation
report
shall
address
bioburden
testing,
pyrogen
testing
and, if
applicable,
testing for
sterilant
residues.
( In the case No No
f of devices measuri
) placed on ng
the market function
N
with a
measuring
function, a
description
of the
methods
used in
order to
ensure the
accuracy
as given in
the
specificatio
ns.
( If the No Standalo
g device is to ne
) be software
connected device
to other
device(s)
in order to
operate as
intended, a
description
of this
combinatio
n/configur
ation
including
proof that
it conforms
to the
general
safety and
performan
ce
requireme
nts when
connected
to any such
device(s)
having
N
regard to
the
characteris
tics
specified
by the
manufactu
rer.
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Checklist: MDR General Safety and Performance Requirements

Chapter I: General Requirements

Chapter II: Requirements Regarding Design and Manufacture

2.3) Infection and Microbiological Contamination

2.4) Devices Incorporating Materials of Biological Origin

2.6) Devices with a Diagnostic or Measurement Function

2.9) Active Devices and Devices Connected to Them

2.11) Protection Against Mechanical and Thermal Risks

Annex II: Technical Documentation

4.1.1) Device Description and Specification

4.1.2) References to Previous and Similar Generations of the Device

4.2) Information to be Supplied by the Manufacturer

4.4) General Safety and Performance Requirements

4.5) Benefit-Risk-Analysis and Risk Management

4.6) Product Verification and Validation

4.6.1) Pre-Clinical and Clinical Data

4.6.2) Additional Information Required in Specific Cases

Template Copyright openregulatory.com. See template license.

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