MDD Classification Document

Mapping of Requirements
NOTE: this template only serves for MDD purposes. From May 2021 on, Annex
VIII MDR applies instead of Annex IX MDD.
Medical Device Directive (MDD) Document Section
Annex IX (All)

Summary
Product: (enter content)
Version: (enter content)
Classification: (enter content)
Rule: (enter content)

Chapter 1: Applicable Definitions

You will need to carefully check and fill out all rows below. Some rows are pre-
filled for applicability under the assumption of a stand-alone software medical
device. However, this is a quite essential document and you’re better off checking
twice.
1.1 Duration

Term Definition Applicable

Transient Normally intended for continuous
use for less than 60 minutes.
Short term Normally intended for continuous
use for not more than 30 days.
Long term Normally intended for continuous
use for more than 30 days.

1.2 Invasive Devices

Definition Applicable
Invasive deviceA device which, in whole No
or in part, penetrates inside the body,
either through a body orifice or through
the surface of the body.Body orificeAny
natural opening in the body, as well as the
external surface of the eyeball, or any
permanent artificial opening, such as a
stoma.Surgically invasive deviceAn
Definition Applicable
invasive device which penetrates inside the
body through the surface of the body, with
the aid or in the context of a surgical
operation. For the purposes of this
Directive devices other than those referred
to in the previous subparagraph and which
produce penetration other than through an
established body orifice, shall be treated as
surgically invasive devices.Implantable
deviceAny device which is intended:— to
be totally introduced into the human body
or,— to replace an epithelial surface or the
surface of the eye, by surgical intervention
which is intended to remain in place after
the procedure.Any device intended to be
partially introduced into the human body
through surgical intervention and intended
to remain in place after the procedure for
at least 30 days is also considered an
implantable device.

1.3 Reusable Surgical Instrument

Definition Applicable
Instrument intended for surgical use by No
cutting, drilling, sawing, scratching,
scraping, clamping, retracting, clipping or
similar procedures, without connection to
any active medical device and which can be
reused after appropriate procedures have
been carried out.

1.4 Active Medical Device

Definition Applicable
Any medical device operation of which Yes
depends on a source of electrical energy or
any source of power other than that
directly generated by the human body or
gravity and which acts by converting this
energy. Medical devices intended to
transmit energy, substances or other
elements between an active medical device
and the patient, without any significant
Definition Applicable
change, are not considered to be active
medical devices.Stand alone software is
considered to be an active medical device.

1.5 Active Therapeutical Device

Definition Applicable
Any active medical device, whether used
alone or in combination with other medical
devices, to support, modify, replace or
restore biological functions or structures
with a view to treatment or alleviation of
an illness, injury or handicap.

1.6 Active Device for Diagnosis

Definition Applicable
Any active medical device, whether used
alone or in combination with other medical
devices, to supply information for
detecting, diagnosing, monitoring or
treating physiological conditions, states of
health, illnesses or congenital deformities.

1.7 Central Circulatory System

Definition Applicable
For the purposes of this Directive, ‘central
circulatory system’ means the following
vessels:arteriae pulmonales, aorta
ascendens, arcus aorta, aorta descendens
to the bifurcatio aortae, arteriae
coronariae, arteria carotis communis,
arteria carotis externa, arteria carotis
interna, arteriae cerebrales, truncus
brachio- cephalicus, venae cordis, venae
pulmonales, vena cava superior, vena cava
inferior.

1.8 Central Nervous System

Definition Applicable
For the purposes of this Directive, ‘central
nervous system’ means brain, meninges
and spinal cord.
Chapter 2: Implementing Rules
Rules Applicable
2.1: Application of the Yes
classification rules shall be
governed by the intended
purpose of the devices.
2.2: If the device is intended
to be used in combination
with another device, the
classification rules shall
apply separately to each of
the devices. Accessories are
classified in their own right
separately from the device
with which they are used.
2.3: Software, which drives
a device or influences the
use of a device, falls
automatically in the same
class.
2.4: If the device is not
intended to be used solely
or principally in a specific
part of the body, it must be
considered and classified on
the basis of the most critical
specified use.
2.5: If several rules apply to
the same device, based on
the performance specified
for the device by the
manufacturer, the strictest
rules resulting in the higher
classification shall apply.
2.6: In calculating the
duration referred to in
Section 1.1 of Chapter I,
continuous use means ‘an
uninterrupted actual use of
the device for the intended
purpose’. However where
usage of a device is
discontinued in order for
the device to be replaced
Rules Applicable
immediately by the same or
an identical device this shall
be considered an extension
of the continuous use of the
device.

Chapter 3: Classification Rules

1.) Non-Invasive Devices

Rules Applicable
Rule 1All non-invasive
devices are in Class I, unless
one of the rules set out
hereinafter applies.
Rule 2All non-invasive No
devices intended for
channelling or storing
blood, body liquids or
tissues, liquids or gases for
the purpose of eventual
infusion, administration or
introduction into the body
are in Class IIa:— if they
may be connected to an
active medical device in
Class IIa or a higher class—
if they are intended for use
for storing or channelling
blood or other body liquids
or for storing organs, parts
of organs or body tissues.In
all other cases they are in
Class I.
Rule 3All non-invasive No
devices intended for
modifying the biological or
chemical composition of
blood, other body liquids or
other liquids intended for
infusion into the body are in
Class IIb, unless the
treatment consists of
filtration, centrifugation or
Rules Applicable
exchanges of gas, heat, in
which case they are in Class
IIa.
Rule 4All non-invasive No
devices which come into
contact with injured skin:—
are in Class I if they are
intended to be used as a
mechanical barrier, for
compression or for
absorption of exudates,—
are in Class IIb if they are
intended to be used
principally with wounds
which have breached the
dermis and can only heal by
secondary intent,— are in
Class IIa in all other cases,
including devices
principally intended to
manage the micro-
environment of a wound.

2.) Invasive Devices

Rules Applicable
Rule 5All invasive devices No
with respect to body
orifices, other than
surgically invasive devices
and which are not intended
for connection to an active
medical device or which are
intended for connection to
an active medical device in
Class I:— are in Class I if
they are intended for
transient use,— are in Class
IIa if they are intended for
short-term use, except if
they are used in the oral
cavity as far as the pharynx,
in an ear canal up to the ear
drum or in a nasal cavity, in
Rules Applicable
which case they are in Class
I,— are in Class IIb if they
are intended for long-term
use, except if they are used
in the oral cavity as far as
the pharynx, in an ear canal
up to the ear drum or in a
nasal cavity and are not
liable to be absorbed by the
mucous membrane, in
which case they are in Class
IIa.All invasive devices with
respect to body orifices,
other than surgically
invasive devices, intended
for connection to an active
medical device in Class IIa
or a higher class, are in
Class IIa.
Rule 6All surgically invasive No
devices intended for
transient use are in Class IIa
unless they are:— intended
specifically to control,
diagnose, monitor or
correct a defect of the heart
or of the central circulatory
system through direct
contact with these parts of
the body, in which case they
are in Class III,— reusable
surgical instruments, in
which case they are in Class
I,— intended specifically for
use in direct contact with
the central nervous system,
in which case they are in
Class III,— intended to
supply energy in the form of
ionising radiation in which
case they are in Class IIb,—
intended to have a
biological effect or to be
wholly or mainly absorbed
Rules Applicable
in which case they are in
Class IIb,— intended to
administer medicines by
means of a delivery system,
if this is done in a manner
that is potentially
hazardous taking account of
the mode of application, in
which case they are in Class
IIb.
Rule 7All surgically invasive No
devices intended for short-
term use are in Class IIa
unless they are intended:—
either specifically to
control, diagnose, monitor
or correct a defect of the
heart or of the central
circulatory system through
direct contact with these
parts of the body, in which
case they are in Class III,—
or specifically for use in
direct contact with the
central nervous system, in
which case they are in Class
III,— or to supply energy in
the form of ionizing
radiation in which case they
are in Class IIb,— or to have
a biological effect or to be
wholly or mainly absorbed
in which case they are in
Class III,— or to undergo
chemical change in the
body, except if the devices
are placed in the teeth, or to
administer medicines, in
which case they are in Class
IIb.
Rule 8All implantable No
devices and long-term
surgically invasive devices
are in Class IIb unless they
Rules Applicable
are intended:— to be placed
in the teeth, in which case
they are in Class IIa,— to be
used in direct contact with
the heart, the central
circulatory system or the
central nervous system, in
which case they are in Class
III,— to have a biological
effect or to be wholly or
mainly absorbed, in which
case they are in Class III,—
or to undergo chemical
change in the body, except if
the devices are placed in the
teeth, or to administer
medicines, in which case
they are in Class III.

3.) Additional Rules Applicable to Active Devices

Rules Applicable
Rule 9All active therapeutic
devices intended to
administer or exchange
energy are in Class IIa
unless their characteristics
are such that they may
administer or exchange
energy to or from the
human body in a potentially
hazardous way, taking
account of the nature, the
density and site of
application of the energy, in
which case they are in Class
IIb.All active devices
intended to control or
monitor the performance of
active therapeutic devices
in Class IIb, or intended
directly to influence the
performance of such
devices are in Class IIb.
Rules Applicable
Rule 10Active devices
intended for diagnosis are
in Class IIa:— if they are
intended to supply energy
which will be absorbed by
the human body, except for
devices used to illuminate
the patient’s body, in the
visible spectrum,— if they
are intended to image in
vivo distribution of
radiopharmaceuticals,— if
they are intended to allow
direct diagnosis or
monitoring of vital
physiological processes,
unless they are specifically
intended for monitoring of
vital physiological
parameters, where the
nature of variations is such
that it could result in
immediate danger to the
patient, for instance
variations in cardiac
performance, respiration,
activity of CNS in which
case they are in Class
IIb.Active devices intended
to emit ionizing radiation
and intended for diagnostic
and therapeutic
interventional radiology
including devices which
control or monitor such
devices, or which directly
influence their
performance, are in Class
IIb.
Rule 11All active devices
intended to administer
and/or remove medicines,
body liquids or other
substances to or from the
Rules Applicable
body are in Class IIa, unless
this is done in a manner:—
that is potentially
hazardous, taking account
of the nature of the
substances involved, of the
part of the body concerned
and of the mode of
application in which case
they are in Class IIb.
Rule 12All other active
devices are in Class I.

4.) Special Rules

Rules Applicable
Rule 13All devices No
incorporating, as an integral
part a substance which, if
used separately, can be
considered to be a
medicinal product, as
defined in Article 1 of
Directive 2001/83/EC, and
which is liable to act on the
human body with action
ancillary to that of the
devices, are in Class III. All
devices incorporating, as an
integral part, a human
blood derivative are in Class
III.
Rule 14All devices used for No
contraception or the
prevention of the
transmission of sexually
transmitted diseases are in
Class IIb, unless they are
implantable or long term
invasive devices, in which
case they are in Class III.
Rule 15All devices intended No
specifically to be used for
disinfecting, cleaning,
Rules Applicable
rinsing or, when
appropriate, hydrating
contact lenses are in Class
IIb. All devices intended
specifically to be used for
disinfecting medical devices
are in Class IIa. Unless they
are specifically to be used
for disinfecting invasive
devices in which case they
are in Class IIb.This rule
does not apply to products
that are intended to clean
medical devices other than
contact lenses by means of
physical action.
Rule 16Devices specifically No
intended for recording of X-
ray diagnostic images are in
Class IIa.
Rule 17All devices No
manufactured utilizing
animal tissues or
derivatives rendered non-
viable are Class III except
where such devices are
intended to come into
contact with intact skin
only.
Rule 18By derogation from No
other rules, blood bags are
in Class IIb.

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