GHTF STUDY GROUP 1 PRE-MARKET EVALUATION DOCUMENTS

GHTF STUDY GROUP 1
PRE-MARKET EVALUATION
DOCUMENTS
BY RICHA TRIVEDI
ROLLNO – 10
MPHARM SEM II

INTRODUCTION
• The Global Harmonization Task Force (GHTF) was founded in 1993.
• The Global Harmonization Task Force (GHTF) was a voluntary group of representatives from
national medical device regulatory authorities and the regulated industry. Since its inception, the
GHTF was comprised of representatives from five founding members grouped into three
geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates
medical devices using their own unique regulatory framework.
• The purpose of the GHTF was to encourage convergence in regulatory practices related to
ensuring the safety, effectiveness/performance and quality of medical devices, promoting
technological innovation and facilitating international trade, and the primary way in which this
was accomplished was via the publication and dissemination of harmonized guidance documents
on basic regulatory practices. These documents, which were developed by five (5) different GHTF
Study Groups, can be adopted/implemented by member national regulatory authorities. The
relationships between the work of each Study Group can be represented schematically.
• The GHTF also served as an information exchange forum through which countries with medical
device regulatory systems under development could benefit from the experience of those with
existing systems and/or pattern their practices upon those of GHTF founding members

ABOUT STUDY GROUPS
• Global Harmonization Task Force (GHTF) Study Groups were established under the Procedural
Document, “GHTF Roles and Responsibilities”.
• Generally the GHTF had five Study Groups that address premarket through postmarket medical
device issues.
• To access archived documents regarding the GHTF Study Groups, see the GHTF Archived
• To access final documents regarding the GHTF Study Groups, see the Documents page.
• Study Group 1 - Premarket Evaluation
• Study Group 2 - Post-Market Surveillance/Vigilance
• Study Group 3 - Quality Systems
• Study Group 4 - Auditing
• Study Group 5 - Clinical Safety/Performance

DOCUMENT 1
INTRODUCTION:
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.
Avoid placing unnecessary burdens upon the regulated industry.
Title: Principles of Conformity
Assessment for Medical Devices
GHTF/SG1/N78:2012

CONTINUE ……
• This document supersedes GHTF/SG1/N15:2006 which provided guidance
on the same topic. It has been modified to:
• Clarify the basis of allocating medical devices to one of four classes;
• Change the rule applying to sterilisation and disinfection devices;
Remove the inconsistency Summary Technical Documentation for
Demonstrating Conformity to the Essential Principles of Safety and
Performance of Medical Devices (STED);
• Add a Section on the reclassification of medical devices; and • incorporate
changes resulting from the public scrutiny process

DEFINITIONS
1)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.
2) 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.
3)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.
4) 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.
5) 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.
6)Central nervous system: The brain, meninges, and spinal cord.
7)Cleaning: Removal of contamination from an item to the extent necessary for its further processing and its
intended subsequent use.

• 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

DURATION OF
USE
Transient
• Normally intended for continuous
use for less than 60 minutes
Short term
• Normally intended for continuous use for
between 60 mins and 30 days
Long term
• Normally intended for continuous use for more
than 30 days

• INVASVIVE DEVICE
• Invasive device: A device, which, in whole or in part, penetrates
inside the body, either through a body orifice or through the
surface of the body.
• Body orifice: Any natural opening in the body, as well as the
external surface of the eyeball, or any permanent artificial opening,
such as a stoma or permanent tracheotomy.
• Surgically invasive device:
• (a) An invasive device which penetrates inside the body through the
surface of the body, with the aid or in the context of a surgical
operation.

• Implantable device: Any device, including those that are partially or wholly absorbed,
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.
• Lay person: Individual that does not have formal training in a relevant field or
discipline.
• Life supporting or life sustaining: A device that is essential to, or that yields
information that is essential to, the restoration or continuation of a bodily function
important to the continuation of human life.
• Medical device: See GHTF guidance document: Definition of the Term ‘Medical
Device’.
Implantable device:

• Reusable surgical instrument: Instrument intended for surgical use by
cutting, drilling, sawing, scratching, scraping, clamping, retracting,
clipping or similar surgical 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.
• 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.

GENERAL PRINCIPLES
• Manufacturers of medical devices are subject to regulatory
controls overseen by national RAs.
• The RA specifies procedures to be followed by manufacturers
during the design, manufacture, and marketing of each device,
and describes the manner in which a manufacturer should
demonstrate conformity to such procedures.• It is widely accepted that oversight of these procedures by the RA should increase in
line with the potential of a medical device to cause harm to a patient or user (i.e. the
hazard it presents), and to do so without placing an unwarranted increase in the cost
of regulatory compliance for either the manufacturer or RA, or delay market entry

• In practice, this is best achieved by assigning every medical
device into one of four groups – or ‘classes’ - by applying the
classification rules described in this guidance document, and
specify in separate guidance.Customarily, a classification
system of this type is referred to as a ‘risk-based classification
scheme’ but this is a misnomer since the rules take account
only of the hazard presented by a particular device and the
different conformity assessment procedures that should apply
to each group of devices. not the probability harm will occur

• The RA takes account of the probability that harm will occur by
modifying the evidence requirements at the conformity
assessment stage rather than modifying the classification rules.
Probability of harm is influenced by factors such as whether: .
• the technology is regarded as mature;
• the device type is the source of many adverse event reports;
• the device’s manufacturer has a long experience of the device
and the technologies it embodies;
• the device user is a lay person.

CLASSIFICATION SYSTEM FOR MEDICAL
DEVICES
• Structure of the Classification Rules
• a) RAs should establish a device classification system consisting of four classes where Class A
represents the lowest hazard and Class D the highest.
• b) The determination of class should be based on rules derived from the potential of a medical device
to cause harm to a patient or user (i.e. the hazard it presents) and thereby on its intended use and the
technology/ies it utilises.
• c) These rules should allow a manufacturer to readily identify the class of its particular medical device
subject, where appropriate, to the RA resolving any matters of interpretation.
• d) The rules should be capable of accommodating future technological developments.
• e) The manufacturer should document its justification for placing its product into a particular class,
including the resolution of any matters of interpretation where it has asked a RA for a ruling.
• f) An accessory to a medical device may be classified separately using the classification rules in this
guidance document.

• g) If, based on the manufacturer’s 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 manufacturer’s 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

g)If, based on the manufacturer’s 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 manufacturer’s 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.

• 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.
• 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.
• 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.

DIAGRAMMATIC REPRESENTATION OF THE CLASSIFICATION
SYSTEM
CLASS LEVEL DEVICE EXAMPLES
A Low Hazard Bandages / tongue depressors
B Low-moderate
Hazard
Hypodermic Needles / suction
equipment
C Moderate-high
Hazard
Lung ventilator / bone fixation plate
D High Hazard Heart valves / implantable
defibrillator
Figure 1: Classification System for Medical Devices

DEVICE CLASS
A B C D
REGULATORY
REQUIREMENTS
HIGHER
LOWER
Figure 2: Conceptual illustration of
regulatory controls increasing with
device class

CONTINUE…..
• Figure 2 indicates increasing regulatory controls as the device class progresses
from Class A to Class D. Such controls may require, for example:-
• the manufacturer to apply an independently audited quality management system
to the design and development process as well as to manufacturing;
• the RA or CAB to review the manufacturer’s Summary Technical Documentation,
including the clinical evidence provided, to verify conformity to all relevant
Essential Principles, prior to the device being placed on the market;
• the manufacturer to undertake post-market evaluation and testing of marketed
devices.
• The concept is expanded in the GHTF guidance document entitled Principles of
Conformity Assessment for Medical Devices.

CLASSIFICATION RULES
• The actual classification of each device depends on the claims made by the
manufacturer for its intended use and the technology/ies it utilises. As an aid to
interpreting the purpose of each rule, illustrative examples of medical devices
that should conform to the rule have been provided in the table below.
However, it must be emphasised that a manufacturer of such a device should
not rely on it appearing as an example but should instead make an independent
decision on classification taking account of its particular design and intended
use.
• As an aid to understanding how these rules may be applied, a series of decision
trees are provided in Appendix A. These are for illustrative purposes only and
are not intended to be a substitute for the rules themselves.
• Manufacturers, RAs and CABs are advised to refer to the definitions in Section
4.0 of this document for a proper understanding of the terms used within these
rules.

Non-Invasive Devices
Rule 5
Invasive through body
orifice or stoma
(not surgically)
Short term use
Class
B
INVASIVE DEVICES (1 of 2)
Rule 6
Surgically invasive
- transient use < 60 mins
Class
B
Long term use
Class
C
Transient use
Class
A
If connected
to an active
medical device
of Class B
or higher
Class
B
Used in oral
cavity, ear canal
or nasal cavity only
Class
A
Intended to diagnose, monitor
or correct a defect of heart or
central circulatory system
and in direct contact with it
Class
D
A reusable
surgical instrument
Class
A
Supplies energy as
ionizing radiation
Class
C
UNLESS
Biological effect
or mainly
absorbed
Class
C
Administers
medicinal products
in a potentially
hazardous manner
Class
C
Used in oral
cavity, ear canal
or nasal cavity
only &
not likely to
be absorbed
by mucous
membrane
Class
B
UNLESS
UNLESS
For use in direct
contact with central
nervous system
Class
D

Class
B
INVASIVE DEVICES (2 of 2)
Rule 8
Surgically invasive
- long term use > 30 days
- implant
Class
C
Undergoes chemical change
in the body (excluding teeth)
Class
D
Used in direct contact
with the heart,
central circulatory
system or central
nervous system
Class
D
Life supporting or
life sustaining
Class
D
Biological effect
or mainly absorbed
Class
D
UNLESS
Rule 7
Surgically invasive
- short term use 60 min to 30 days
Class
B
Intended to diagnose, monitor
or correct a defect of heart or
central circulatory system
and in direct contact with it
Class
D
Administers medicinal products
Class
C
Undergoes chemical
change in the body
(excluding teeth)
Class
C
Biological effect
or mainly absorbed
Class
D
Use in direct contact
with the central
nervous system
Class
D
UNLESS
Supplies ionizing
radiation
Class
C
Active implants
Class
D
Administers
medicines
Class
D
Breast implants
Class
D
Placed in
/on teeth

Rule9(ii)
Intended to control,
monitor or directly
influence the
performance of
active therapeutic
devices in Class C
Class
C
UNLESS
Rule9(i)
Active therapeutic
devices intended to
administer or
exchange energy
Class
B
Used to administer /
exchange energy
(including ionizing
radiation)
in a potentially
hazardous way
Class
C
Rule10(ii)
Devices emitting ionizing
radiation for diagnostic or
therapeutical
interventional radiology,
including their
controls & monitors
Class
C
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 radio-
pharmaceuticals
Class
B
The absorbed
energy is for
illumination only
Class
A
UNLESS
ACTIVE DEVICES (1 of 2)
Diagnosis / monitoring
where the patient is,
or could be,
in immediate
danger
Class
C

Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic
(IVD) Medical Device’( Document 2)
(revision of GHTF/SG1/N29:2005)
1. Rationale
The development of consistent, harmonized definitions for the terms ‘medical device’, and an ‘In Vitro
Diagnostic medical device’, that could be used within a global regulatory model would offer significant
benefits to the manufacturer, user, patient or consumer, and to Regulatory Authorities and support global
convergence of regulatory systems. Eliminating differences between jurisdictions decreases the cost of
gaining regulatory compliance and allows patients earlier access to new technologies and treatments
Definitions
Accessory to a medical device: means an article intended specifically by its manufacturer to be used together with a
particular medical device to enable or assist that device to be used in accordance with its intended use.
Accessory to an IVD medical device: means an article intended specifically by its manufacturer to be used together
with a particular IVD medical device to enable or assist that device to be used in accordance with its intended use.

Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical
Device’
Medical Device
‘Medical device’ means any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use,
software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for
human beings, for one or more of the specific medical purpose(s) of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease,
 diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
 investigation, replacement, modification, or support of the anatomy or of a physiological process,
 supporting or sustaining life,
 control of conception,
 disinfection of medical devices,
 providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the
human body, but which may be assisted in its intended function by such means.
‘In Vitro Diagnostic (IVD) medical device’ means a medical device, whether used alone or in
combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human
body solely or principally to provide information for diagnostic, monitoring or compatibility purposes.

REGISTRATION OF MANUFACTURERS AND OTHER
PARTIES AND LISTING OF
MEDICAL DEVICES
Rationale
• In many jurisdictions where regulations for medical devices are
introduced for the first time, the initial step in the process is
often the collection by the RA of information relating to:
• the types of medical devices supplied to the market,
• the manufacturers of these devices, and
• other parties responsible for supplying them to the market in
that jurisdiction
GHTF/SG1/N065:2010

• This guideline offers definitions for the terms ‘registration’ and ‘listing’. It clarifies
the roles and responsibilities of those entities involved in supplying a medical device
to the market, such as the manufacturer, authorised representative, distributor and
importer, with respect to registration and listing. It also provides guidance on the
data content for registration and listing.
•
• This document will have as its audience RAs and those parties involved in supplying
medical devices to the market. It should assist jurisdictions introducing medical
device regulations for the first time and those revising existing registration and
listing regulations. In addition, this guidance is expected to improve the clarity of
other GHTF harmonized guidance documents with respect to registration and listing.
Scope
• This guidance applies to all products that fall within the GHTF definition of a
medical device that appears within the GHTF document Information Document
Concerning the Definition of the Term “Medical Device”, including those used for the
in vitro diagnostic examination of specimens derived from the human body.
Purpose

DEFINITIONS
• Contact details: means a postal address in a format that allows physical
location to be established together with a telephone number and e-mail
address.
• Listing: the process whereby a party submits information to the
Regulatory Authority in a jurisdiction, regarding the identification of a
medical device(s) that is or will be supplied to the market in that
jurisdiction.
• Supply(ing) to the market: the making available, in return for payment
or free of charge, of a device, other than a device intended for clinical or
performance evaluation, with a view to distribution and/or use on the
market.
• Registration: the process by which a party submits information to the
Regulatory Authority in a jurisdiction, regarding the identification and
establishment location(s) of
• the manufacturer and other parties, responsible for supplying a medical

REGISTRATION
• General
• Registration provides information on the parties that are or will be, supplying medical
devices to the market that is within the RA’s jurisdiction.
• The RA should identify unambiguously which parties are required to provide it with
registration information.
• Providing registration information to the RA does not remove from that party (i.e. the
registering party) its obligation to comply fully with other regulatory requirements
that apply to it within the jurisdiction.
• Parties subject to registration
• Medical device manufacturers, authorised representatives, importers and distributors
may be subject to registration requirements.

Timing of registration
• A registering party should submit all necessary information to
the RA before it is involved in the supply of any medical device
to the market for the first time.
• Note: When the registration database is first established, some
of the parties subject to registration will already be supplying
medical devices to the market. Such parties should be allowed
a reasonable period of time to comply with the new registration
requirements.

Information to be submitted for registration purposes
For the purposes of registration, and irrespective of device classification, each registering
party should submit the following information to the RA.
1. An indication of whether the registering party is a manufacturer, an authorised
representative, an importer or a distributor of medical devices supplied to the market of the
jurisdiction where the information is being collected. Some registering parties will fall into
more than one of these categories.
2. Name and contact details of the place of business of the registering party, together with
the name and post held of the person within that organisation responsible for the
registration.
3. Where the registering party has contracted another party to complete the registration
process on its behalf (see 5.2.2), the name and contact details of the place of business of
that other party, together with the name and post held of the person providing the required
information.
4. An indication that the information provided is either a new entry or an update of
previously submitted information. If the second situation applies, the registration code
previously allocated to the registered party (see Section 5.5 bullet 8) should be provided. 5.
The date when the information is submitted.

Role of the Regulatory Authority The RA is responsible for:
• identifying which of the parties listed in Section 5.2.1 is required to provide information to
it;
• specifying the information it requires from each registering party (see Section 5.4);
• specifying the format, mechanism and frequency with which the registration information is
to be provided;
1. Role of the Registering Party
The registering party is required to:
 provide the RA with the registration information specified in Section 5.4;
 attest to its accuracy;
 update the information provided within 30 calendar days of the occurrence of any change, or when
requested to do so by the RA, in order to maintain the accuracy of the registration information;
 respond to the RA’s request to confirm that the information provided for registration purposes
continues to be accurate.

1. Medical Device Listing
1. General
1. Listing provides information on medical devices that are or will be, supplied to the market that is within the RA’s
jurisdiction.
2. The RA should identify unambiguously which parties are required to provide it with listing information.
3. Providing listing information to the RA does not remove from the party providing such information (i.e. the listing
party) its obligation to comply fully with all the other regulatory requirements that apply to it within the jurisdiction.
Parties subject to listing requirements
Medical device manufacturers, authorised representatives, importers and distributors may be subject to
listing requirements.
The listing party should be registered with the RA according to the provisions of Section 5 of this
document.
While retaining responsibility, any party required to provide listing information may contract another party
to complete the listing process on its behalf.

Role of the listing party
The listing party is required to:
 provide the RA with the listing information specified in Section 6.4;
 attest to its accuracy;
 update the information provided within 30 calendar days of becoming aware of the
occurrence of any change, or when requested to do so by the RA, in order to
maintain the accuracy of the listing database;
 respond to the RA’s request to confirm that the information provided for device
listing purposes continues to be accurate.

GHTF/SG1/N055: 2009
Definitions of the Terms Manufacturer, Authorised Representative, Distributor and
Importer.
Purpose
This document is intended to provide harmonized definitions of the terms “manufacturer”,
“authorised representative”, “distributor” and “importer”. These terms appear in guidance
documents published by the Global Harmonization Task Force. Adopting the definitions from this
document will allow a Regulatory Authority to identify the various persons making a medical device
available for use and their different roles.
This document is intended to serve as guidance for Regulatory Authorities, Conformity
Assessment Bodies and the regulated industry. It should assist jurisdictions introducing medical
device regulations for the first time and also improve understanding of existing GHTF guidance
documents.
Scope
This document applies to those products which fall within the definition of a medical device that
appears within the GHTF document Information Document Concerning the Definition of the Term
“Medical Device

1. Definitions of the terms “manufacturer”, “authorised representative”, “distributor” and
“importer”
A single party may fulfil one or more of these roles, e.g. a manufacturer may not only distribute the products it
manufactures but it may also act as a distributor of devices from a different manufacturer.
Manufacturer
“Manufacturer” means any natural or legal person with responsibility for design and/or
manufacture of a medical device with the intention of making the medical device available for use,
under his name; whether or not such a medical device is designed and/or manufactured by that
person himself or on his behalf by another person(s).
The term “person” that appears here and in the other definitions of this document, includes legal
entities such as a corporation, a partnership or an association.
Authorised Representative
“Authorised representative” means any natural or legal person established within
a country or jurisdiction who has received a written mandate from the
manufacturer to act on his behalf for specified tasks with regard to the latter’s
obligations under that country or jurisdiction’s legislation.

Distributor
“Distributor” means any natural or legal person in the supply chain who, on his own
behalf, furthers the availability of a medical device to the end user.
NOTES:
1. More than one distributor may be involved in the supply chain.
2. Persons in the supply chain involved in activities such as storage and transport on behalf of
the manufacturer, importer or distributor, are not distributors under this definition.
Importer
“Importer” means any natural or legal person in the supply chain who is the first in a supply
chain to make a medical device, manufactured in another country or jurisdiction, available in
the country or jurisdiction where it is to be marketed.

N046:2008
Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
Rationale
In general, the degree of involvement of the Regulatory Authority
or Conformity Assessment Body in such reviews is proportional
to the risks associated with a particular category of devices

PURPOSE AND SCOPE
To describe:
•An overview of the available conformity assessment elements to demonstrate conformity to the
Essential Principles of Safety and Performance of Medical Devices;
•the conformity assessment elements that should apply to each class of device such that the
regulatory demands are proportional to the risk class of the IVD medical device;
•the manufacturer’s responsibilities to provide evidence that the IVD medical device is safe and
performs as intended by the manufacturer;
• the responsibilities of a Regulatory Authority (RA), or Conformity Assessment Body (CAB)
appointed by or acting on behalf of the RA, to confirm that the conformity assessment elements
are properly applied by the manufacturer
Scope
his document applies to all products that fall within the definition of an IVD medical device that appears in the GHTF
document Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

DEFINITIONS
• Audit: a systematic and independent examination to determine whether quality
activities and related results comply with planned arrangements and whether these
arrangements are implemented effectively and are suitable to achieve objectives.
• Authorized Representative: means any natural or legal person established within a
country or jurisdiction who has received a mandate from the manufacturer to act on
his behalf for specified tasks with regard to the latter’s obligations under that
country or jurisdiction’s legislation
• Conformity Assessment: the systematic examination of evidence generated and
procedures undertaken by the manufacturer, under requirements established by the
Regulatory Authority, to determine that a medical device is safe and performs as
intended by the manufacturer and, therefore, conforms to the Essential Principles of
Safety and Performance of Medical Devices (SG1/N041).
•
• Conformity Assessment Body (CAB): a body engaged in the performance of
procedures for determining whether the relevant requirements in technical
regulations or standards are fulfilled. A CAB is authorized to undertake specified
conformity assessment activities by a RA that will ensure performance of the CAB is
monitored and, if necessary, withdraw designation.

CONTINUE….
• Recognised Standards: standards deemed to offer the presumption of conformity to
specific essential principles of safety and performance
•
• Regulatory Authority (RA): a government body or other entity that exercises a
legal right to control the use or sale of medical devices within its jurisdiction, and that
may take enforcement action to ensure that medical products marketed within its
jurisdiction comply with legal requirements.
•
• Summary Technical Documentation (STED): a summary of technical documentation
submitted for conformity assessment purposes.
•
• Technical Documentation: the documented evidence, normally an output
• of the quality management system, that demonstrates compliance of a device to the
Essential Principles of Safety and Performance of Medical Devices (SG1/N041).

Conformity Assessment Elements
• The conformity assessment elements that the RA may include in a conformity assessment system are:
•a quality management system
•a system for post-market surveillance
•summary technical documentation
•a declaration of conformity
•the registration of manufacturers and their IVD medical devices by the RA.
 All five elements are applicable to each of the device classes. Where there are alternatives within a conformity assessment element,
the manufacturer
may choose the one that it believes to be most suitable.
 The conformity assessment elements that appear in this Section describe the tasks of the manufacturer and, where appropriate,
the responsibilities of the RA or CAB.
 Although the RA/CAB responsibilities for Class C and Class D IVD medical devices are the same, it needs to be understood that the
STED for a Class C IVD medical device will contain less elaborate information than the STED for a Class D device. The main difference
for a Class D STED would be in the level of details in the clinical/performance data and details of the manufacturer’s QC release program.
The RA/CAB should in the review process not normally require more elaborate information for a Class C device however this does not
preclude the RA/CAB from requesting such information in specific cases

• The requirements for a quality management system that is accepted by RAs for regulatory purposes and based on
international recognised standards2 for medical devices, combined with the other conformity assessment elements,
are intended to ensure that IVD medical devices will be safe and perform as intended by the manufacturer.
• A manufacturer needs to demonstrate its ability to provide IVD medical devices that consistently meet both customer
and regulatory requirements. Manufacturers demonstrate compliance through an established and effectively
implemented quality management system that meets the regulatory requirements.
• The scope and complexity of the quality management system that a manufacturer needs to establish is influenced by
varying needs, objectives, the products provided, processes employed, the size and structure of the organisation, and
the specific regulatory requirements.
• Processes required by the quality management system but carried out on the manufacturer’s behalf by third parties
remain the responsibility of the manufacturer and are subject to control under the manufacturer’s quality
management system.The RA/CAB should assess the adequacy of this control as part of the conformity assessment
process.
• The extent of the RA/CAB assessment of the manufacturer’s quality management system is influenced by the class of
the IVD medical device. For Class B, C and D devices, the RA or CAB needs to be satisfied that the manufacturer has
an effective quality management system in place, appropriate for the device under assessment. In doing this, the RA
or CAB will consider any relevant existing certification and, if not satisfied, e.g. with its scope or with post-market
performance history, may carry out an on-site audit of the manufacturer’s facility.
• The RA may issue separate guidance on the acceptance by CABs of existing certification. Manufacturers of Class C and
D devices should have a full quality management system3 that includes design and development. Manufacturers of
1. Quality management system (QMS)

expected to have the basic elements of a QMS in place but need not include design and
development activities.
The QMS for manufacturers of Class A devices is normally not subject to premarket on-site
audit by the RA or CABSystem for post market surveillance
Prior to placing the product on the market, the manufacturer will put in place, as part of its quality management system, a process to
assess the continued conformity of the device to the Essential Principles of Safety and Performance throughout the IVD medical device
lifecycle. This process will include, at a minimum, complaint handling, vigilance reporting, and corrective and preventive action[1].
The RA or CAB may confirm that such a process is in place, usually at the time of the quality management system audit[2].
Technical documentation
1.The technical documentation provides the evidence that the IVD medical device meets the Essential Principles.
For the purposes of conformity assessment, the manufacturer will establish a subset of technical documentation (Summary Technical
Documentation (STED)) to be submitted, as required by the class of the device. A description of that subset will be provided in the GHTF
guidance document: Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of
IVD Medical Devices (STED). The extent of evidence in that STED is likely to increase with the class of the IVD medical device and its
complexity.
The RA or CAB determines the adequacy of the documented evidence in support of the manufacturer’s Declaration of Conformity to the
Essential Principles through a review of the STED. The depth and the timing of the review is likely to be influenced by the risk class of the IVD
medical device and its complexity.

DECLARATION OF CONFORMITY
One element of the GHTF regulatory model for IVD medical devices requires that the manufacturer attest that its
IVD medical device complies fully with all applicable Essential Principles for Safety and Performance
as documented in a written ‘Declaration of Conformity’ (DOC).
• At a minimum, this declaration should contain the following information:
• A statement that each device that is the subject of the declaration:
complies with the applicable Essential Principles for Safety and Performance,
has been classified according to the classification rules, and
has met all the applicable conformity assessment elements.

 Information sufficient to identify the device/s to which the Declaration of Conformity applies.
 A Global Medical Device code and term for the device/s.
 The risk class allocated to the device/s after following the guidance found in Principles of In Vitro Diagnostic
(IVD) Medical Devices Classification6.
 Which of the conformity assessment procedures described in Section 6.2 have been applied.
 The date from which the Declaration of Conformity is valid.
 The name and address of the device manufacturer.
 The name, position and signature of the responsible person who has been authorised to complete the
Declaration of Conformity upon the manufacturer’s behalf.
The RA or CAB may review and confirm the adequacy of the Declaration of Conformity, if required, by
examining the supporting documents or other evidence.
Continue ……

Registration of manufacturers and their IVD medical devices by the Regulatory Authority
Registration of both the manufacturers and their IVD medical devices by the RA is considered to be the most basic level of
regulatory control of devices in the market. This registration system will identify the IVD medical device/s and the party responsible
for the IVD medical device/s within the particular jurisdiction, thereby facilitating any regulatory activity.
Prior to placing an IVD medical device on the market, the manufacturer, its local distributor or its Authorized Representative should provide the Regulatory Authority
with the required information.
The RA will maintain the register.
1. Harmonized Conformity Assessment System
1.The relationship between conformity assessment and device classification
The GHTF recommends that each IVD medical device be allocated to one of four classes, using a set of rules as defined in the GHTF document
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification. Class A devices are the lowest risk devices, Class B are moderate to low risk,
Class C aremoderate to high risk andClass D devices present the highest risk. The level of scrutiny and evidence needed to demonstrate
that the IVD medical device meets the Essential Principles of Safety and Performance and conformity assessment procedures should be
proportional to the risk class of the IVD medical device
This principle is illustrated in the tables that follow. The tables identify available conformity assessment elements and propose a combinatio
be applied to different classes of IVD medical devices to construct a harmonized conformity assessment system that may be adopted as par
regulatory model for IVD medical devices.Where there are alternatives within conformity assessment elements, e.g. the quality managemen
Class A or Class B device may be either a full quality management system or one without design and development control, the manufacturer
believes to be most suitable

The four tables below summarise conformity assessment
elements that apply to Class A, B, C and D devices
CLASS “A” DEVICE
Conformity
Assessment
Element
Manufacturer Responsibility RA / CAB Responsibility Section
Quality
Management
System
(QMS)
Establish and maintain a full
QMS
or
a QMS without design and
development controls.
Premarket regulatory audit not
required.
5.1
Post Market
Surveillance
Establish and maintain an
adverse event reporting
procedure according to GHTF
SG2 guidance.
May audit post-market to
investigate specific safety or
regulatory concerns.
5.2
Technical
Documentation
Upon request prepare STED. Premarket submission of STED not
required. May be requested to
investigate specific safety or
regulatory concerns.
5.3
Declaration of
Conformity
Prepare, sign and maintain. On file with the manufacturer;
available upon request.
5.4
Registration of
manufacturers
and their devices
Perform according to
regulatory requirements.
Maintain and verify as appropriate. 5.5

CLASS “B” DEVICE
Conformity
Assessment
Element
Quality
Management
System (QMS)
QMS
or
a QMS without design and
development controls.
Be satisfied that a current and
appropriate QMS is in place or
otherwise conduct a QMS audit prior
to marketing authorization.
5.1
Post Market
Surveillance
SG2 guidance.
appropriate adverse event reporting
procedure is in place as part of the
QMS.
5.2
Technical
Documentation
Upon request prepare STED. Premarket submission normally not
required but if requested, receive and
conduct a review of the STED to
determine conformity to Essential
Principles.
5.3
Declaration of
Conformity
Prepare, sign and submit. Review and verify compliance with
requirements.
5.4
Registration of
manufacturers
and their devices

CLASS “C” DEVICE
Conformity
Assessment
Element
Quality
Management
System (QMS)
QMS.
otherwise conduct a QMS audit
prior to marketing authorization.
5.1
Post Market
Surveillance
SG2 guidance.
appropriate adverse event reporting
procedure is in place as part of the
QMS.
5.2
Technical
Documentation
Prepare and submit STED for
review.
Receive and conduct a premarket
review of the STED to determine
conformity to Essential Principles.
5.3
Declaration of
Conformity
Prepare, sign and submit. Review and verify compliance with
requirements.
5.4
Registration of
manufacturers
and their
devices

CLASS “D” DEVICE
Conformity
Assessment
Element
Quality
Management
System (QMS)
Establish and maintain a
full QMS.
otherwise conduct a QMS audit
prior to marketing authorization.
5.1
Post Market
Surveillance
procedure according to
GHTF SG2 guidance.
appropriate adverse event
reporting procedure is in place as
part of the QMS.
5.2
Technical
Documentation
Prepare and submit STED
for review. A STED for this
class should contain more
extended information such
as full performance
evaluation reports.
Receive and conduct a premarket
review of the STED to determine
conformity to Essential Principles.
5.3
Declaration of
Conformity
Prepare, sign and submit. Review and verify compliance
with requirements.
5.4
Registration of
manufacturers
and their
devices
Maintain and verify as
appropriate.
5.5

Role of Standards in the Assessment of Medical Devices N044:2008
1. Rationale
International consensus standards are a tool for harmonizing regulatory processes to assure the safety, quality and performance of medical
devices. This document provides guidance on the use of standards by a manufacturer when demonstrating the device conforms to relevant essential
safety and performance principles.
1. Purpose
1. encourage and support the development of international consensus standards for medical devices that may serve to demonstrate conformity with
the Essential Principles of Safety and Performance of Medical Devices (hereafter referred to as ‘Essential Principles’);
2. encourage manufacturers to conform with appropriate international standards;
3. persuade Regulatory Authorities to introduce a mechanism for recognising standards that provide manufacturers with a method of demonstrating
conformity with the GHTF harmonized Essential Principles;
 support the concept that in general, the use of standards is voluntary and manufacturers have the option to select alternative solutions to
demonstrate their medical device meets the relevant Essential Principles.

Definitions of the Terms
Manufacturer, Authorised
Representative, Distributor and
Importer.
N055R6

N045:2008
Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
Rationale
This guidance document is one of a series that together describe a global regulatory model for medical devices. It provides guidance
on the principles of classification of IVD medical devices.
Since the inter-relationship between device class and conformity assessment is critical in establishing a consistent approach to
premarket approval across all countries/regions, it should be read in conjunction with the GHTF document on Principles of Conformity
Assessment for In Vitro Diagnostic (IVD) Medical Devices that recommends procedures that may be used to demonstrate that an IVD
medical device conforms to the Essential Principles of Safety and Performance for Medical Devices
1.Purpose
The purpose of this document is to
•assist a manufacturer to allocate its IVD medical device to an appropriate risk class using a set of harmonized classification principles;
•base such classification principles on an IVD medical device’s intended use ;
•allow Regulatory Authorities to rule upon matters of interpretation for a particular IVD medical device, when appropriate.
Subsequently, such classification will determine the conformity assessment route as described in the GHTF document on Principles of Conformity Assessment for
In Vitro Diagnostic (IVD) Medical Devices
1.Scope
This document applies to all products that fall within the definition of an IVD medical device. An IVD medical device is defined as a device which,
whether used alone or in combination, is intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or
principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen
receptacles, software, and related instruments or apparatus or other articles. Note: International reference materials (e.g. WHO) and materials used for
external quality assessment schemes are excluded.

The Classification of an IVD medical device is based on the following criteria:
•the intended use and indications for use as specified by the manufacturer (including but not limited to specific disorder,
populations, condition or risk factor for which the test is intended)
•the technical/scientific/medical expertise of the intended user (lay person or healthcare professional)
•the importance of the information to the diagnosis (sole determinant or one of several), taking into consideration the natural
history of the disease or disorder including presenting signs and symptoms which may guide a physician
•the impact of the result (true or false) to the individual and/or to public health
General Principles

•Proposed General Classification System for IVD Medical Devices
A four class system is proposed. The use of an alphabetical system in this document is chosen as a distinctive format
for GHTF
CLASS RISK LEVEL EXAMPLES
A Low Individual Risk
and Low Public
Health Risk
Clinical Chemistry Analyser , prepared selective
culture media
B Moderate Individual
Risk and/or Low
Public Health Risk
Vitamin B12, Pregnancy self testing,
Anti-Nuclear Antibody, Urine test strips
C
High Individual Risk
and/or Moderate
Public Health Risk
Blood glucose self testing, HLA typing,
PSA screening, Rubella
D High Individual Risk
and High Public
Health Risk
HIV Blood donor screening, HIV Blood diagnostic

Figure 2 shows a conceptual illustration of increasing levels of regulatory requirements as the device risk class
increases. These may include, for example:
 operation of a quality system (recommended for all devices);
 documentation of clinical evidence to support the manufacturer’s specified intended use;
 the need for technical data;
 product testing using in-house or independent resources;
 the need for and frequency of independent external audit of the manufacturer’s quality system; and
 independent external review of the manufacturer’s technical data.
The concept is expanded in the GHTF guidance document entitled Principles of Conformity Assessment for In Vitro
Diagnostic (IVD) Medical Devices

Figure 2: Conceptual illustration of regulatory
requirements increasing with device risk class.
Device Class: A B C D
Regulatory
requirements
HIGHER
LOWER

The Determination of Device Class
•The Determination of Device Class
The manufacturer should:
•Decide if the product concerned is an IVD medical device based on the intended use and the indications for
use using the definition in section 4.0 of this document.
•Take into consideration all the rules as listed in section 9.0 in order to establish the proper classification for the
device. Where an IVD medical device has multiple intended uses as specified by the manufacturer, which
place the device into more than one class, it will be classified in the higher class.
•Where more than one of the classification rules applies to the IVD medical device, it should be allocated to the
highest class indicated, e.g. a self-testing for HIV would be a class D under rule 1 and not a class C under rule
4.
Determine that the device is not subject to special national rules that apply within a particular jurisdiction

GHTF STUDY GROUP 1 PRE-MARKET EVALUATION DOCUMENTS

GHTF STUDY GROUP 1 PRE-MARKET EVALUATION DOCUMENTS

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