Professional Documents
Culture Documents
Clasificacion Equipos Médicos
Clasificacion Equipos Médicos
Table of Contents
1.0
Introduction ................................................................................................................... 4
2.0
Rationale, Purpose and Scope...................................................................................... 5
2.1 Rationale ......................................................................................................................... 5
2.2 Purpose ............................................................................................................................ 5
2.3 Scope ............................................................................................................................... 5
3.0
References ...................................................................................................................... 5
4.0
Definitions ...................................................................................................................... 6
5.0
General Principles ......................................................................................................... 8
6.0
Classification System for Medical Devices ................................................................. 9
6.1 Structure of the Classification Rules ............................................................................... 9
6.2 Diagrammatic Representation of the Classification System ......................................... 10
6.3 Manufacturers Determination of Device Class ............................................................ 12
7.0
Classification Rules ..................................................................................................... 12
7.1 Non-Invasive Devices ................................................................................................... 12
7.2 Invasive Devices ........................................................................................................... 14
7.3 Active Devices .............................................................................................................. 18
7.4 Additional Rules ........................................................................................................... 21
7.5 Rationale for the inclusion of the Additional Rules within this document ................... 22
8.0
Reclassification of Medical Devices ........................................................................... 23
Appendix A: Decision trees to illustrate how the rules may be used to classify specific
devices. ................................................................................................................................. 24
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Preface
The document herein was produced by the Global Harmonization Task Force, a
voluntary group of representatives from medical device Regulatory Authorities and the
regulated industry. The document is intended to provide non-binding guidance for use in the
regulation of medical devices, and has been subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution, translation or use of this
document. However, incorporation of this document, in part or in whole, into any other
document does not convey or represent an endorsement of any kind by the Global
Harmonization Task Force.
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1.0 Introduction
The primary way in which the GHTF achieves its goals is through the production of a
series of guidance documents that together describe a global regulatory model for medical
devices. The purpose of such guidance is to harmonize the documentation and procedures that
are used to assess whether a medical device conforms to the regulations that apply in each
jurisdiction. Eliminating differences between jurisdictions decreases the cost of gaining
regulatory compliance and allows patients earlier access to new technologies and treatments.
This document has been developed to encourage and support global convergence of
regulatory systems. It is intended for use by Regulatory Authorities (RAs), Conformity
Assessment Bodies (CABs) and industry, and will provide benefits in establishing, in a
consistent way, an economic and effective approach to the control of medical devices in the
interest of public health. It seeks to strike a balance between the responsibilities of RAs to
safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens
upon the regulated industry.
This document should be read in conjunction with the GHTF document entitled
Principles of Conformity Assessment for Medical Devices that prescribes conformity
assessment requirements appropriate to each of the four classes proposed herein. The link
between device classification and conformity assessment is fundamental to the development of
an effective global regulatory model. If such is adopted in a consistent manner by all
jurisdictions, the goal of a premarket approval for a particular device being accepted globally,
may be achieved.
This document supersedes GHTF/SG1/N15:2006 which provided guidance on the
same topic. It has been modified to:
Where other guidance documents within the series are referenced within this text, their
titles are italicised for clarity.
Study Group 1 of the Global Harmonization Task Force (GHTF) has prepared this
guidance document. Comments or questions about it should be directed to either the Chair or
Secretary of GHTF Study Group 1 whose contact details may be found on the GHTF website 1.
www.ghtf.org
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Rationale
It is widely accepted that there should be a method to separate medical devices into a
small number of groups, or classes, and subsequently apply different conformity assessment
techniques to each class. The global adoption of a rules-based classification procedure would
offer significant benefits to manufacturers, users, patients, and RAs and support global
convergence of regulatory systems.
2.2
Purpose
To stipulate a series of principles and rules that allow a medical device to be assigned to
one of four classes based on its intended use, and thereby:
assist a manufacturer to allocate its medical device to an appropriate class using
a set of classification rules; and
allow RAs to pronounce upon matters of interpretation for a particular medical
device, when required so to do.
Subsequently, such classification will determine the conformity assessment procedures
that will be applied to the device.
This document is intended for use by RAs, CABs and the regulated Industry,
2.3
Scope
This document applies to all products that fall within the definition of the term medical
device, other than IVD medical devices, for which a separate classification document is
available on the GHTF website.
3.0 References 2
GHTF/SG1/N44:2008 Role of Standards in the Assessment of Medical Devices.
GHTF/SG1/N68:2012 Essential Principles of Safety and Performance of Medical Devices.
GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices.
GHTF/SG1/N071:2012 Definition of the Terms Medical Device and In Vitro Diagnostic
(IVD) Medical Device.
GHTF/SG1/N78:2012 Principles of Conformity Assessment for Medical Devices.
The listed documents are subject to periodic review and may be superseded by later versions. The reader is
encouraged to refer to the GHTF website to confirm whether the referenced documents remain current.
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4.0 Definitions
Accessory to a medical device: Means an article intended specifically by its manufacturer to be
used together a particular medical device to enable or assist that device to be used in
accordance with its intended use.
Active medical device: Any medical device, operation of which 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 change, are not considered to be active medical devices.
Standalone software is considered to be an active medical device.
Active therapeutic device: 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 or injury.
Active device intended for diagnosis: 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.
Central circulatory system: The major internal blood vessels including the following:
pulmonary veins, pulmonary arteries, cardiac veins, coronary arteries, carotid arteries
(common, internal and external), cerebral arteries, brachiocephalic artery, aorta
(includes all segments of the aorta), inferior and superior vena cava and common iliac
arteries.
Central nervous system: The brain, meninges, and spinal cord.
Cleaning: Removal of contamination from an item to the extent necessary for its further
processing and its intended subsequent use.
Disinfection: Reduction of the number of viable microorganisms on a product to a level
previously specified as appropriate for its intended further handling or use.
Duration of use
Transient: Normally intended for continuous use for less than 60 minutes.
Short term: Normally intended for continuous use for between 60 minutes and 30 days.
Long term: Normally intended for continuous use for more than 30 days.
NOTE: continuous use means:
a) The entire duration of use of the same device without regard to temporary
interruption of use during a procedure or, temporary removal for purposes such as
cleaning or disinfection of the device.
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procedures, without connection to any active medical device and which are intended by
the manufacturer to be reused after appropriate procedures for cleaning and/or
sterilisation have been carried out.
Risk: Combination of the probability of occurrence of harm and the severity of that harm.
Sterilisation: Validated process used to render product free from viable microorganisms.
NOTE: In a sterilisation process, the nature of microbial inactivation is exponential and
thus the survival of a microorganism on an individual item can be expressed in terms of
probability. While this probability can be reduced to a very low number, it can never
be reduced to zero.
Vital physiological process: Means a process that is necessary to sustain life, the indicators of
which may include any one or more of the following:
respiration;
heart rate;
cerebral function;
blood gases;
blood pressure;
body temperature.
3
4
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the devices manufacturer has a long experience of the device and the
technologies it embodies;
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g) If, based on the manufacturers intended use, two or more classification rules apply to
the device, the device is allocated the highest level of classification indicated.
h) Where one medical device is intended to be used together with a different medical
device, that may or may not be from the same manufacturer, (e.g. a pulse oximeter and
a replaceable sensor sourced from a different manufacturer, or a general purpose
syringe and a syringe driver), the classification rules should apply separately to each of
the devices.
i) Classification of an assemblage of medical devices that individually comply with all
regulatory requirements depends on the manufacturers purpose in packaging and
marketing such a combination of separate devices. For example:
If the combination results in a product that is intended by the manufacturer to
meet a purpose different from that of the individual medical devices that make it
up, the combination is a new medical device in its own right and should be
classified according to the new intended use.
If the combination is for the convenience of the user but does not change the
intended uses of the individual medical devices that make it up (e.g. a
customised kit that provides all the devices necessary to carry out a particular
surgical procedure), the classification allocated to the assemblage for the
purpose of a Declaration of Conformity is at the level of the highest classified
device included within it.
j) Classification of an assemblage of medical devices where one or more of the medical
devices that is in the assemblage has yet to comply with all the relevant regulatory
requirements, should be for the combination as a whole according to its intended use.
k) While most software is incorporated into the medical device itself, some is not.
Provided such standalone software falls within the scope of the definition for a medical
device, it is deemed to be an active device and should be classified as follows:
Where it drives or influences the use of a separate medical device, it should be
classified according to the intended use of the combination.
Where it is independent of any other medical device, it is classified in its own
right using the rules in Section 7.0 of this document.
l) The historical experience of a RA may require a particular type of medical device to be
allotted a different classification from that assigned through the application of these
classification rules.
6.2
LEVEL
DEVICE EXAMPLES
Low Hazard
Low-moderate
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Hazard
C
Moderate-high
Hazard
High Hazard
HIGHER
REGULATORY
REQUIREMENTS
LOWER
DEVICE CLASS
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6.3
Non-Invasive Devices
RULE
ILLUSTRATIVE EXAMPLES
Page 12 of 30
RULE
ILLUSTRATIVE EXAMPLES
RULE
ILLUSTRATIVE EXAMPLES
NOTE: In some jurisdictions, blood bags have a
special rule that places them within a different
class.
7.2
Invasive Devices
RULE
ILLUSTRATIVE EXAMPLES
Page 14 of 30
RULE
ILLUSTRATIVE EXAMPLES
Example: urethral stent; contact lenses for longterm continuous use (for this device, removal of
the lens for cleaning is considered as part of the
continuous use).
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RULE
ILLUSTRATIVE EXAMPLES
substances that are excreted without
modification from the body.
Example: Insufflation gases for the abdominal
cavity.
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RULE
ILLUSTRATIVE EXAMPLES
Page 17 of 30
RULE
ILLUSTRATIVE EXAMPLES
Active Devices
RULE
ILLUSTRATIVE EXAMPLES
Such devices are mostly electrically powered
equipment used in surgery; devices for
specialised treatment and some stimulators.
Examples: muscle stimulators; powered dental
hand pieces; hearing aids; neonatal phototherapy
equipment; ultrasound equipment for
physiotherapy.
Page 18 of 30
RULE
ILLUSTRATIVE EXAMPLES
Class C.
Rule 10(i). Active devices intended for
diagnosis are in Class B:
RULE
ILLUSTRATIVE EXAMPLES
on conscious and spontaneously breathing
patients where failure to deliver the appropriate
dosage characteristics is not potentially
hazardous.
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7.4
Additional Rules
RULE
ILLUSTRATIVE EXAMPLES
These medical devices incorporate medicinal
substances in an ancillary role.
Examples: antibiotic bone cements; heparincoated catheters; wound dressings incorporating
antimicrobial agents to provide ancillary action
on the wound; blood bags incorporating an anticoagulant.
NOTE: In some jurisdictions such products:
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RULE
ILLUSTRATIVE EXAMPLES
7.5
Rationale for the inclusion of the Additional Rules within this document
There are a small number of products that fall within the scope of the definition of a
medical device and which may need to be classified to take account of factors other than those
covered by the general rules (Rules 1 to 12). While GHTF continues to support and encourage
regulatory harmonisation, it recognises that a particular RA may have to reflect different local
needs or social considerations when it introduces regulations on the classification of a minority
of medical devices. Additional rules 13 to 17 provide examples of where this may occur.
For the understanding of those countries that are not Founding Members of GHTF, it is
felt important to offer guidance on the classification of such devices. Therefore, five
Additional Rules are provided (Rules 13 to 17).
Matters that may need to be considered are: Rule 13:
Rule 14:
Rule 15:
Rule 16:
Rule 17:
Contraceptive devices
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Page 24 of 30
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INVASIVE DEVICES (1 of 2)
Rule 5
Invasive through body
orifice or stoma
(not surgically)
Rule 6
Surgically invasive
transient use < 60 mins
Class
B
UNLESS
A reusable
surgical instrument
Transient use
Class
A
Class
A
Supplies energy as
ionizing radiation
Class
C
UNLESS
Class
B
UNLESS
Class
C
Class
A
Administers
medicinal products
in a potentially
hazardous manner
Used in oral
cavity, ear canal
or nasal cavity
only &
not likely to
be absorbed
by mucous
membrane
Class
B
Used in oral
cavity, ear canal
or nasal cavity only
Class
C
Biological effect
or mainly
absorbed
If connected
to an active
medical device
of Class B
or higher
Class
B
Class
C
Class
D
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INVASIVE DEVICES (2 of 2)
Rule 7
Surgically invasive
- short term use 60 min to 30 days
UNLESS
Class
B
UNLESS
Rule 8
Surgically invasive
long term use > 30 days
- implant
Class
C
Placed in
/on teeth
Supplies ionizing
radiation
Life supporting or
life sustaining
Active implants
Biological effect
or mainly absorbed
Biological effect
or mainly absorbed
Administers
medicines
Class
D
Class
D
Class
D
Class
D
Class
B
Class
D
Class
C
Class
C
Class
D
Class
D
Class
D
Class
D
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ACTIVE DEVICES (1 of 2)
Rule9(i)
Active therapeutic
devices intended to
administer or
exchange energy
Rule10(i)
Active diagnostic
devices intended
to allow direct
diagnosis / monitoring of
vital physiological processes
OR supply energy that
is absorbed
OR intended to image
in vivo radiopharmaceuticals
Class
B
UNLESS
Class
B
UNLESS
Used to administer /
exchange energy
(including ionizing
radiation)
in a potentially
hazardous way
The absorbed
energy is for
illumination only
Class
C
Rule9(ii)
Intended to control,
monitor or directly
influence the
performance of
active therapeutic
devices in Class C
Class
C
Rule10(ii)
Devices emitting ionizing
radiation for diagnostic or
therapeutical
interventional radiology,
including their
controls & monitors
Class
C
Class
A
Diagnosis / monitoring
where the patient is,
or could be,
in immediate
danger
Class
C
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ACTIVE DEVICES (2 of 2)
Rule 11
To
administer or
remove medicinal
products & other
substances
from the body
Class
B
Rule 12
Active devices
other than
those where
Rules 9, 10
or 11 apply
Class
A
UNLESS
In a
potentially
hazardous
manner
Class
C
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ADDITIONAL RULES
Rule 13
Device incorporating
medicinal product
which has
ancillary action
Rule17
Device used for
contraception
or prevention of
of sexually
transmitted
diseases
Rule 15
Device intended
specifically for
sterilising or
disinfecting
medical devices
Class
D
Class
B
Rule 14
Device manufactured
from or incorporating
human or animal
tissues, cells or
derivatives thereof
Rule 16
Device used for
disinfecting,
cleansing, rinsing
or hydrating of
contact lenses
Class
C
UNLESS
Class
D
UNLESS
Class
C
Disinfection solutions
OR
washer-disinfectors
intended specifically
for invasive
devices as the end
point of processing
UNLESS
Class
C
OR
UNLESS
Non-viable animal
tissues or
derivatives thereof
& in contact with
intact skin only
Implantable or
long-term invasive
Class
D
Class
A
Class
A
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