Medical Device Classification

Medical Device Classification

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Description: Factors That May Affect Risk: -Device design should incorporate the principles of inherent safety. Manufacturing processes must be well planned and under control. The validated process ensures conforming output and reduces the compromise to safety.

This is the objective intent of the manufacturer on how the device will be used. The intended use will define the “scope” of use, and, in particular, places where the device is not intended for use. Define the anticipated user.

Identify the expected user’s skill level-Home use devices should be simple to operate, Complex devices may require higher levels of training.

 
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Contents:
Medical Device Classification
Dan O’Leary CBA, CQA, CQE, CRE, SSBB, CIRM
President
Ombu Enterprises, LLC
Dan@OmbuEnterprises.com
www.OmbuEnterprises.com
603-209-0600

Medical Device Classification

Ombu Enterprises, LLC

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Speaker Biography


Dan O’Leary
– Dan O’Leary is President of Ombu Enterprises, LLC, an education,
training, and consulting company focusing on Operational Excellence
using analytical skills and a systems approach to operations
management.
– Dan has more than 30 years experience in quality, operations, and
program management in regulated industries including aviation,
defense, medical devices, and clinical labs.
– He holds a Masters Degree in Mathematics; is an ASQ certified
Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability
Engineer, and Six Sigma Black Belt; and is certified by APICS in
Resource Management.



Ombu Enterprises, LLC
– Ombu works with small manufacturing companies, offering training and
execution in Operational Excellence. Focusing on the analytic skills and
systems approach of operations management, Ombu helps companies
achieve efficient, effective process and regulatory compliance.

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Outline








The Concepts Of Medical Device Risk
Classification in the US (FD&CA)
Classification in the EU (MDD)
Classification in Canada (CMDR)
GHTF Guidance
Summary and Conclusions
Questions

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The Concepts of Medical
Device Risk

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Factors That May Affect Risk
• Design
– Device design should incorporate the
principles of inherent safety

• Manufacture
– Manufacturing processes must be well
planned and under control
– Validated process ensure conforming output
and reduce the compromise to safety
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Factors That May Affect Risk
• Intended Use
– This is the objective intent of the manufacturer on
how the device will be used.
– The intended use will define the “scope” of use, and,
in particular, places where the device is not intended
for use

• User experience, education, and training
– Define the anticipated user
– Identify the expected user’s skill level
• Home use devices should be simple to operate
• Complex devices may require higher levels of training
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Factors That May Affect Risk
• Device should not compromise
– The clinical condition of patients
– The safety of patients
– Safety or health of users

• Acceptable risks
– Risks are acceptable when weighed against patient
benefits
– Compatible with a high level of health and safety

• Risk/benefit analysis
– X-rays are inherently dangerous
– X-ray machines have a benefit in diagnosis
– The benefit of imaging outweighs the exposure risk
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Regulatory Controls
• Regulators ensure public health and safety
– Regulations try to match the level of control with the
risk
– The overarching goal is appropriate control
commensurate with risk!

• The methods to approach regulatory controls
differ by geographic market
• Controls follow the market, not the
manufacturing location
– Product marketed in the EU and manufactured in the
US must follow EU regulations
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Control Level

Concept of Control v. Risk

The risk classes and the
control levels are discrete.
Typically, a regulatory system
will have 3 or 4 risk classes.

Device Risk
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Classification in the US

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Devices Classes
• Device classes (and controls) in the US
are defined by law
• The Food, Drug, and Cosmetic Act
(FD&CA) defines the classes as:
– Class I, General Controls
– Class II, Special Controls
– Class III, Premarket Approval

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General Controls
• The FD&CA lists the General Controls as references to
sections of the law.
• In general, they are:






Cannot be adulterated (must follow the regulations)
Cannot be misbranded (must have accurate labels and labeling)
The firm must register with the FDA
The firm must list its devices with the FDA
Cannot be a banned device (unreasonable and substantial risk
of illness or injury)
– Not subject to recall (or similar action)
– The firm must maintain certain records and reports
– The firm must apply good manufacturing practices

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Special Controls
• General controls are not sufficient, by
themselves, to provide reasonable assurance of
the safety and effectiveness of the device
• Special controls include:





performance standards
postmarket surveillance
patient registries
guidelines (including clinical data in premarket
notification)
– other appropriate actions
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Premarket Approval
• General controls and Special controls are not know to be
sufficient to ensure the safety and efficacy of the device.
• Application for premarket approval include:
– Reports of investigations to show whether or not such device is
safe and effective
– a statement of the components, ingredients, and properties and
of the principle or principles of operation, of the device
– a description of the methods, facilities, and control for the
manufacture, processing, packing, and installation of the device
– Reference to any relevant performance standards and the
device ability to meet the performance standard
– Sample of the device and components
– Proposed labeling
– Certification related to clinical trials
– Other relevant information the FDA may require
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The Controls
• For each device, the FDA determines the Class.
– Class I devices require general controls
– Class II devices require general control and special
controls
– Class III devices require general controls, special
controls, and premarket approval

• The are exceptions and exemptions for certain
devices
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Who Classifies Devices



The law requires a recommendation from panels based on medical
specialties
The current panels are:

















Anesthesiology
Cardiovascular
Clinical Chemistry and Clinical Toxicology
Dental
Ear, Nose, and Throat
Gastroenterology and Urology
General and Plastic Surgery
General Hospital and Personal Use
Hematology and Pathology
Immunology and Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Physical Medicine
Radiology
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The Panels
• The panel examines the device type
• The panel classifies the device as I, II, or III.
• The panel can exempt certain parts of the
regulations:
– Premarket notification
– Good manufacturing practices

• When accepted, the panel’s recommendations
are published as regulations

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Two Dimensional Classification
• In the US, every device is classified along two
dimensions:
– Each device is assigned a panel
– The panel determines the Class and other controls
and exemptions

• The outcome is a regulation that specifies the
class, special controls, exemptions, etc.
• All of the information is available on the FDA
website.
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Classification Example #1
• Blood pressure cuff











Regulation Description: Blood pressure cuff
Definition: A blood pressure cuff is a device that has an inflatable
bladder in an elastic sleeve (cuff) with a mechanism for inflating the
bladder. The cuff is used to determine a subject's blood pressure.
Regulation Medical Specialty: Cardiovascular
Review Panel:
Cardiovascular
Product Code:
DXQ
Submission Type:
510(k)
Regulation Number:
870.1120
Device Class:
2
GMP Exempt?
No
Recognized Consensus Standards
– AAMI SP10:2002 Manual, electronic or automated sphygmomanometers



Guidance Document
– Non-Automated Sphygmomanometer (Blood Pressure Cuff) Guidance
Version 1; Final



Third Party Review:

Medical Device Classification

Eligible for Accredited Persons Program
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Classification Example #1
(cont.)
Sec. 870.1120 Blood pressure cuff.
(a) Identification. A blood pressure cuff is a device
that has an inflatable bladder in an inelastic
sleeve (cuff) with a mechanism for inflating and
deflating the bladder. The cuff is used in
conjunction with another device to determine a
subject's blood pressure.
(b) Classification. Class II (performance
standards).
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Classification Example #2
• Infant Heel Warmer











Device:
Regulation Description:
Regulation Medical Specialty:
Review Panel:
Product Code:
Submission Type:
Regulation Number:
Device Class:
GMP Exempt?
Guidance Document

Infant heel warmer (chemical heat pack)
Hot or cold disposable pack.
Physical Medicine
Physical Medicine
MPO
510(k)
890.5710
1
No

– Guidance Document for the Preparation of Premarket Notification [510(k)]
Applications for Heating and Cooling Devices



Third Party Review:

Medical Device Classification

Eligible for Accredited Persons Program

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Classification Example #2
(cont.)
Sec. 890.5710 Hot or cold disposable pack
(a) Identification. A hot or cold disposable pack is a device
intended for medical purposes that consists of a sealed
plastic bag incorporating chemicals that, upon
activation, provides hot or cold therapy for body
surfaces.
(b) Classification. Class I (general controls). Except when
intended for use on infants, the device is exempt from
the premarket notification procedures in subpart E of
part 807 of this chapter subject to 890.9.
Notice that the device class remains constant, but the regulatory
requirements change with the intended use (adult or infant).
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Classification Example #3









Device:
Stent, coronary
Definition: This device is a metal scaffold placed via a delivery catheter into the
coronary artery or saphenous vein graft to maintain the lumen.
Review Panel:
Cardiovascular
Product Code:
MAF
Submission Type:
PMA
Device Class:
3
GMP Exempt?
No
Recognized Consensus Standards






Guidance Document




ASTM F2079-02 Standard Test Method for Measuring Recoil of Balloon-Expandable
Stents
ASTM F2129-06 Standard Test Method for Conducting Cyclic Potentiodynamic
Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant
Devices
ASTM F2081-06 Standard Guide for Characterization and Presentation of the
Dimensional Attributes of Vascular Stents
Non-Clinical Tests and Recommended Labeling for Intravascular Stents and
Associated Delivery Systems - Guidance for Industry and FDA Staff

Third Party Review

Medical Device Classification

Not Third Party Eligible
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Premarket Notification
• Many device types require Premarket
Notification.
– Typically, these are Class II devices
– Section 510(k) of the FD&CA created this
approach, so they are typically called a 510(k)

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Substantial Equivalence
• One approach in the premarket notification
submission (510(k)) demonstrates the device is
"substantially equivalent“ to a legally marketed
device.
• Substantially equivalent means:
– the same intended use as the predicate device
– the same technological characteristics as the
predicate device, or
– has different technological characteristics but is as
safe and effective as a legally marketed device, and
– does not raise different questions of safety and
effectiveness than the predicate device
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Basic Control

Class I
Class II
Class III

General
Controls
YES
YES
YES

Special
Controls

Premarket
Approval

YES
YES

YES

Note: Some specific devices may be exempt from the
requirements shown here. Always check the
regulation for the device type.
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US Summary





Three device classes (I, II, and III)
Classification determined by the FDA
Controls depend upon the classification
For “existing” devices, Premarket
Notification establishes a chain of
predicate devices
• For “new” devices, Premarket Approval
demonstrates the device is safe and
effective.
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Classification in the EU (MDD)

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Product Directives
• The EU uses a system of product
directives.
• Each directive applies to a particular kind
of product.
• The manufacturer must determine the
applicable directives.

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Directives Related to Medical
Devices
• The EU has three directives that apply to
medical devices.
– Active Implantable Medical Devices are
controlled by the AIMDD
– In Vitro Diagnostic Devices are controlled by
the IVDD
– All other medical devices are controlled by the
MDD

• We will discuss the MDD only
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MDD Revisions
• A revision of the MDD goes into effect at
the end of March 2010.
• Our presentation is based on the revised
version.
• The same general principles apply to both
versions.

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The Notified Body
• The EU does not have a government
organization equivalent to the FDA.
• Devices are put on the market following
conformity assessment methods.
• Conformity assessment is risk based, using
device classification, and may involve a Notified
Body.
• A Notified Body is a private company that you,
as the manufacturer, hire.
• Notified Bodies are accredited by organizations
in the Member States.
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Basic Definitions
• Notification – An act whereby a Member State informs
the Commission and the other Member States that a
body, which fulfils the relevant requirements, has been
designated to carry out conformity assessment
according to a directive. Notification of Notified Bodies
and their withdrawal are the responsibility of the notifying
Member State.
• Notified Body – Certification, inspection, or testing body
designated by the Notifying authority of a EU Member
State to perform the Attestation of Conformity of
products within the scope of a New Approach Directive.

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A Simplified Picture
EU Member
States (27)



Accreditation
Bodies

Notified
Bodies

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The Relationships
Member State

Responsible, under the treaty for the
notification process

Accreditation
Body

Evaluates potential notified bodies
on behalf of the member state

Notified
Body

Performs services for a
manufacturer placing a product on
the market in the EU

Manufacturer
Customer
Medical Device Classification

Places the product on the market
Purchases and uses the product
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Modules
• The conformity paths are based on the
concept of modules
• Each directive implements the appropriate
methods based on the directive.

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Module Content
Module

Description

A – Internal control of production

Covers internal design and production control. Does not require a
notified body to take action.

B – EC type-examination certificate

Covers design, and must be followed by a production phase
module. A notified body issues the EC type-examination
certificate

C – Conformity to type

Follows module B. Provides for conformity with the type as
described in the EC type examination certificate. Does not require
a notified body to take action.

D – Production quality assurance

Follows module B. A notified body approves the quality system
for production, and for final product inspection and test.

E – Product quality assurance

Follows module B. A notified body approves the quality system
for final product inspection and test.

F – Product verification

Follows module B. A notified body controls conformity to type as
described in the EC type examination certificate and issues a
certificate of conformity.

G – Unit verification

Each individual product is examined by a notified body who
issues a certificate of conformity.

H – Full quality assurance

A notified body approves the quality system for design,
manufacture, and final product inspection/test.

Note: The structure aligned with the, now superseded, ISO 9001, 9002, & 9003 model.
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Module Scheme
DESIGN PHASE

PRODUCTION PHASE
MODULE A

MODULE C

MODULE D
Manufacturer

MODULE B

CE Mark
MODULE E

MODULE F

MODULE G
MODULE H

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A Look at the MDD

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Where to obtain the Directives
• The best place is the European Commission site
– http://ec.europa.eu
– Click EN (for English)
– Search "List of references of harmonised standards”
(with quotation marks and the British spelling)

• This site contains the directives that require CE
Mark, and other useful information.
– The text of directive and amendments
– Consolidated version of directive
– Lists of references of harmonized standards
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Consolidated Version
• The site has the following entries for the MDD
– Each of the entries has a hyperlink to the documents
– The subject hyperlinks to the Harmonized Standards list
– The MDD has been modified, so there is a consolidated
version

Text of directive and
amendments

Consolidated version of
directive

Subject (short title of directive)

93/42/EEC
98/79/EC
2000/70/EC
2001/104/EC
2007/47/EC

93/42/EEC

Medical devices

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The Device Class
• The manufacturer determines the device class following
the rules in Annex IX
• Determine if the device is invasive or not
– An invasive device, in whole or in part, penetrates inside the
body, either through a body orifice or through the surface of the
body

• Determine if the device is active
– An active device depends on a source of electrical energy (or
any source of power other than that directly generated by the
human body or gravity) and acts by converting this energy

• Determine if any special rules apply
• When multiple rules could lead to different classification,
use the highest risk class.
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Conformity Paths
• The rules lead to multiple paths to
demonstrate conformity
• The device class determines the available
options
• Some of the options require a Notified
Body

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The Annexes
• Annex II EC Declaration Of Conformity
– The manufacturer applies the quality system
approved for the design, manufacture and final
inspection of the products concerned

• Annex III EC Type-examination
– A notified body ascertains and certifies that a
representative sample of the production covered
fulfils the relevant provisions of the Directive

• Annex IV EC Verification
– The manufacturer (or authorized representative)
ensures the products conform to the type described in
the EC type-examination certificate and meet the
requirements of the Directive which apply to them
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The Annexes
• Annex V EC Declaration Of Conformity
– The manufacturer ensures application of the quality system
approved for the manufacture of the products concerned, carries
out the final inspection, and is subject to surveillance

• Annex VI EC Declaration Of Conformity
– The manufacturer ensures application of the quality system
approved for the final inspection and testing of the product and is
subject to surveillance

• Annex VII EC Declaration Of Conformity
– The manufacturer (or authorized representative) prepares
technical documentation.
– This annex has special provisions for sterile devices and devices
with a measuring function
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Class III Devices
Class III

Does not apply to
devices that are
custom made or
intended for clinical
investigation

OR
Annex II

Annex III
OR
Annex IV

Annex V

CE Mark
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Class IIa Devices
Does not apply to
devices that are
custom made or
intended for clinical
investigation

Class IIa
OR
Annex II

Annex VII
OR
Annex IV

Annex V

Annex VI

CE Mark
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Class IIb Devices
Does not apply to
devices that are
custom made or
intended for clinical
investigation

Class IIa
OR
Annex II

Annex III
OR
Annex IV

Annex V

Annex VI

CE Mark
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Class I Devices
Does not apply to
devices that are
custom made or
intended for clinical
investigation

Class I

Annex VII

CE Mark

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Classification Example #1
• Blood pressure cuff
• Invasive or non-invasive: non-invasive
– Doesn’t channel or store fluids for eventual
infusion
– Doesn’t modify blood or other body fluids
– Doesn’t come into contact with injured skin

• Not an active device
• No special rules apply
• Class I by Rule 1
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Classification Example #2
• Infant Heel Warmer
• Invasive or non-invasive: non-invasive
– Doesn’t channel or store fluids for eventual
infusion
– Doesn’t modify blood or other body fluids
– Doesn’t come into contact with injured skin

• Not an active device
• No special rules apply
• Class I by Rule 1
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Classification Example #3
• Coronary Stent
• Invasive or non-invasive: Invasive
– Duration: Long term (Normally intended for
continuous use for more than 30 days)
– Implantable (intended to be totally
introduced into the body by surgery)

• Class III by Rule 8 Point 2 (An
implantable device in direct contact with
the central circulatory system.)
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MDD Summary
• Four device classes (I, IIa, IIb, and III)
• Classification determined by the
manufacturer following a rule based
approach in Annex IX
• Controls depend upon the classification
– Implemented using modules to define the
conformity assessment system

• No distinction between “existing” devices
and “new” devices
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Canadian Medical Device
Regulations

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Canadian Medical Device
Regulations
• The regulations are available on the
Health Canada website
– http://www.hc-sc.gc.ca/dhp-mps/md-im/indexeng.php
– Click on Legislation and Guidelines
– Follow the links to the Justice Canada website

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Medical Device Classes
• Four device classes (I, II, III, or IV)
• Class I represents the lowest risk and
Class IV represents the highest risk
• The classification rules are in SOR/98-282
Schedule 1
– If a medical device can be classified into more
than one class, the class representing the
higher risk applies.
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Schedule 1
Part 1 Non-IVDs
-- Invasive devices
-- Non-invasive devices
-- Active devices
-- Special rules

Medical Device Classification

Part 2 IVDs
-- Use with respect to
Transmissible Agents
-- Other Uses
-- Special Rules

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Regulatory Requirements
• Class II, III, or IV devices require a license
• The required information for a license
changes with the device class

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Classification Example #1
• Blood pressure cuff
• Invasive or non-invasive: non-invasive
– Doesn’t come into contact with injured skin
– Not intended as a mechanical barrier
– Doesn’t channel or store fluids for eventual
infusion
– Doesn’t modify blood or other body fluids

• Not an active device
• No special rules apply
• Class I by Rule 7, subrule (1)
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Classification Example #2
• Infant Heel Warmer
• Invasive or non-invasive: non-invasive





Doesn’t come into contact with injured skin
Not intended as a mechanical barrier
Doesn’t channel or store fluids for eventual infusion
Doesn’t modify blood or other body fluids

• Not an active device
• No special rules apply
• Class I by Rule 7, subrule (1)
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Classification Example #3
• Coronary Stent
• Invasive or non-invasive: Invasive
– “surgically invasive device” means an invasive
device that is intended to enter the body through
an artificially created opening that provides access
to body structures and fluids.

• Class III by Rule 1 Subrule (3) (A surgically
invasive device normally intended to remain
in the body for at least 30 consecutive days.)
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CMDR Summary
• Four device classes (I, II, III, and IV)
• Classification determined by the
manufacturer following a rule based
approach in Schedule 1 Part 1
• Controls depend upon the classification
– Implemented through different licensing
requirements based on the device class

• No distinction between “existing” devices
and “new” devices
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Global Harmonization Task
Force Guidance

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GHTF Overview
• The Global Harmonization Task Force (GHTF) was
conceived in 1992 in an effort to respond to the growing
need for international harmonization in the regulation of
medical devices.
• GHTF has been comprised of representatives from five
founding members (European Union, United States,
Canada, Australia and Japan) grouped into three
geographical areas: Europe, Asia-Pacific and North
America.
• Beginning in 2006, membership expanded to include
three Liaison Body members:
– Asian Harmonization Working Party (AHWP),
– International Organization for Standardization (ISO), and
– International Electrotechnical Commission (IEC).
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GHTF Guidance
• The GHTF web site
– www.ghtf.org

• The GHTF is organized into Study Groups






SG 1 - Premarket Evaluation
SG 2 - Post-Market Surveillance/Vigilance
SG 3 - Quality Systems
SG 4 - Auditing
SG 5 - Clinical Safety/Performance

• SG 1 issued GHTF/SG1/N:15:2006 Principles of
Medical Devices Classification
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The Classification Structure
The document recommends four classes (A, B, C, and D)
Class
A
B
C
D

Risk Level
Low Risk
Lowmoderate
Risk
Moderatehigh Risk
High Risk

Medical Device Classification

Device Examples
Surgical retractors /
tongue depressors
Hypodermic Needles /
suction equipment
Lung ventilator / bone
fixation plate
Heart valves /
implantable defibrillator
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The Classification Structure
• The guidance offers a rule based
approaches
• The rules are divided into:
– Non-invasive Devices
– Invasive Devices
– Active Devices
– Additional Rules

• The guidance document includes decision
trees that help navigate the rule structure
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Conformity Assessment
• GHTF/SG1/N40:2006 Principles of Conformity
Assessment for Medical Devices
• The each device class the document has a table
that defines the activities in:
– Conformity assessment of the QMS
– Conformity assessment of device safety &
performance
– Registration

• It also defines the responsibility of
– The manufacturer
– Regulatory Authority or Conformity Assessment Body
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Classification Example #1
• Blood pressure cuff
• Invasive or non-invasive: non-invasive
– Doesn’t come into contact with injured skin
– Not intended as a mechanical barrier
– Doesn’t channel or store fluids for eventual
infusion
– Doesn’t modify blood or other body fluids

• Not an active device
• No special rules apply
• Class A by Rule 4
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Classification Example #2
• Infant Heel Warmer
• Invasive or non-invasive: non-invasive





Doesn’t come into contact with injured skin
Not intended as a mechanical barrier
Doesn’t channel or store fluids for eventual infusion
Doesn’t modify blood or other body fluids

• Not an active device
• No special rules apply
• Class A by Rule 4
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Classification Example #3
• Coronary Stent
• Invasive or non-invasive: Invasive
– Surgically invasive device: 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.
– Long term duration: Normally intended for
continuous use for more than 30 days.

• Class C by Rule 8
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GHTF Summary
• Four device classes (A, B, C, and D)
• Classification determined by the manufacturer
following a rule based approach supplemented
with decision trees.
• Does not discuss controls, but refers to
GHTF/SG1/N40:2006 Principles of Conformity
Assessment for Medical Devices
• No distinction between “existing” devices and
“new” devices
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Quality Management Systems

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QMS Requirements
Region

Required QMS

US

21 CFR Part 820 Quality System Regulation

EU

EN ISO 13485:2003/AC:2007 Medical devices Quality management systems - Requirements for
regulatory purposes

Canada CAN/CSA-ISO 13485:03 Medical devices - Quality
management systems - Requirements for
regulatory purposes

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Summary & Conclusions

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Summary
• Each region (US, EU, and Canada) has a
system for classification of medical devices
• The device classification determines the
conformity assessment scheme
• In the US, the FDA determines the device class
using medical specialty panels
• In the EU and Canada, the manufacturer applies
a rule based system to determine the class.
• The three systems are not the same, i.e., any
given device could be in a different risk class in
a different system
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Summary
• The GHTF has an approach to
standardize the classification and
regulatory system.
– GHTF/SG1/N15:2006 Principles of Medical
Devices Classification
– GHTF/SG1/N40:2006 Principles of Conformity
Assessment for Medical Devices

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Conclusions
• A manufacturer will often sell devices in
multiple markets.
• The classification and conformity systems
differ in the various markets
– A manufacturer must conform to systems
where the device is marketed

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QUESTIONS
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