GHTF/SG2/N47R4:2005

PROPOSED DOCUMENT
Global Harmonization Task Force

Title: Review of Current Requirements on Postmarket Surveillance

Authoring Group: Study Group 2

Endorsed by: The Global Harmonization Task Force

Date: May 2005

GHTF Chairman

The document herein was produced by the Global Harmonization Task Force, a voluntary
group of representatives from medical device regulatory agencies and the regulated industry.
The document is intended to provide non-binding guidance to regulatory authorities 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 or use of this document; however,
incorporation of this document, in part or in whole, into any other document, or its translation
into languages other than English, does not convey or represent an endorsement of any kind
by the Global Harmonization Task Force.
Copyright © 2000 by The Global Harmonization Task Force
 SG2/N47R4: 2005 Review of Current Requirements on Post-market Surveillance
Study Group 2 - Proposed Document

Table of Contents

Introduction................................................................................................................................4
1.0 Scope..............................................................................................................................4
2.0 References......................................................................................................................4
3.0 Definitions......................................................................................................................4
4.0 Current requirements .....................................................................................................5
4.1 General Descriptions of Post-Market Surveillance....................................................5
4.2 Market surveillance activities carried out by authorities ...........................................6
4.3 Market surveillance activities carried out by manufacturers .....................................9
.

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 SG2/N47R4: 2005 Review of Current Requirements on Post-market Surveillance
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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 agencies and the regulated industry.
The document is intended to provide non-binding guidance to regulatory authorities 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 or use of this document; however,
incorporation of this document, in part or in whole, into any other document, or its translation
into languages other than English, does not convey or represent an endorsement of any kind
by the Global Harmonization Task Force.

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 SG2/N47R4: 2005 Review of Current Requirements on Post-market Surveillance
Study Group 2 - Proposed Document

Introduction

All regulatory systems recognize that adverse event reporting alone cannot capture all risks
related to the use of medical devices. Diagnostic devices where false positive and false
negative are expected, long term implantable devices and devices for home use are examples
of cases where the evaluation of the performance from adverse event reports alone is difficult
or even impossible.

For this reason, various programs for the systematic collection of data on the performance of
devices during the postmarketing phase exist in different countries. At the moment current
requirements, definitions and understanding of Post-Market Surveillance (PMS) activities are
not harmonised. The identification of these programs is required in order to determine, in a
second step, whether harmonisation of some of their aspects may benefit regulatory
authorities and industry.

1.0 Scope
This document provides an overview of the current regulatory requirements for Postmarket
Surveillance in the 5 founding members of GHTF. As such it is meant to be a status
document, representing a brief overview only and does not represent the full scope and nature
of the regulations.

A general description of PMS is given for each founding member. PMS activities are then
divided into Surveillance activities carried out by the authorities and those carried out by the
manufacturers.

2.0 References
None

3.0 Definitions
None

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4.0 Current requirements
AU
4.1 General Descriptions of Post-Market Surveillance
"Medical device post-
market surveillance" means
those activities carried out
(by either the regulator or
the manufacturer) to gain
information about the
quality, safety or
performance of medical
devices which have been
placed in the market. In
contrast to Vigilance, Post
Market Surveillance
measures are usually
proactive.
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SG2/N47R4: 2005 Review of Current Requirements on Post-market Surveillance
CA
The proactive collection of
information on medical
devices could be
considered as post-market
surveillance.
Study Group 2 - Proposed Document
US JP EU
Broadly speaking, Post Market Surveillance There are no explicit
“surveillance” encompasses includes surveillance definitions in the European
all post-approval product activities carried out after directives. However,
monitoring activities and is the products have been "surveillance" is used to
distinct from enforcement. approved by MHLW. indicate active collection of
Surveillance is understood information on medical
Specifically, the term as an active investigation or devices. The wording
“Postmarket Surveillance” survey with the specific "Market Surveillance" is
refers to Section 522 of the purpose of confirming or used to indicate the tasks
Federal Food, Drug, and better defining the safety or carried out by the
Cosmetic Act, which efficacy of a medical authorities, while
defines FDA’s authority to device. "Postmarket Surveillance"
order manufacturers to refers to activities carried
conduct studies of certain out by the manufacturers.
high risk marketed
products.
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AU
4.2 Market surveillance activities carried out by authorities
TGA Surveillance activities
include (but are not
restricted to):
• laboratory testing;
• market surveys of
technical
documentation for
evidence of conformity;
and
• audits of manufacturer
facilities.
The TGA considers the
review of clinical and
technical information
(technical and clinical file websites: Health Canada
audit) to constitute
"Postmarket Monitoring"
As for vigilance, the
regulatory tools available to out fraudulent claims for
the TGA include:
• requiring the
manufacturer or their
authorized
representative to
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Planned testing of devices
on the market: In the past,
Health Canada has tested
devices against standards to
see if they meet those
standards. For example,
condoms and medical
examination gloves were
tested. When non-
compliant products were
found, recalls and other
appropriate actions were
requested.
Proactive review of
has participated in the US
FDA / US Federal Trade
Commission "Surf Day".
This is organized to search
drugs and devices (such as
'cures cancer'). This is not
an on-going activity.
Health Canada has just
Study Group 2 - Proposed Document
US JP EU
Regulatory “surveillance” The term "surveillance" is Medical Device Directives
activities include, but are normally not used to (90/385/EEC; 93/42/EEC;
not limited to: designate the activity of the 98/79/EC): Member States
• Review of mandatory competent authority but shall take all necessary
and voluntary adverse rather for the activity of steps to ensure that devices
event reports; manufacturers and may be placed on the
• Review of required importers. market and put into service
postmarket studies only if they do not
(522); The authority can audit compromise the safety and
• Review of product - and inspect manufacturing health of patients, users
associated clinical trials sites and any other office. and, where applicable,
that were required as a If needed, the authority can other persons when
condition of market order manufacturers and properly installed,
approval; importers to recall, to stop maintained and used in
• Review of product distribution, or to carry out accordance with their
claims, labeling, and any other action for intended purpose.
literature used for ensuring the safety of
promotion and patients and medical staffs. Guide to the
advertising; Implementation of
• Inspection of In addition to that, there Directives Based on New
manufacturer are the reevaluation schema Approach and Global
procedures for product and the reexamination Approach, "Blue Guide":
complaint handling schema for reviewing the Market surveillance
• Developing safety contents of approval. authorities should have the
alerts, public health Under the reexamination necessary resources and
notifications and other scheme the efficacy and powers to conduct their
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AU CA US JP EU
provide information instituted an inspection publications about safety of a new device on surveillance activities. This
(samples, test results, programme for medical suspected device the basis of results of is to monitor products
documentation) relating device importers, problems and investigations conducted by placed on the market and,
to quality safety and distributors and Class I distributing them to the manufactures for a period in cases of non-compliance,
performance of the device manufacturers that public. of four or seven years after to take appropriate action
product upon request as compliments the 3rd party • Ensuring public access the approval are reviewed. to enforce conformity. [...]
a standard condition of audits of manufacturers of to information taken The period is fixed on the To be able to monitor
approval; Class II, III and IV to and reported to the approval. Reevaluation is products placed on the
• the authority to seize assess conformance with Agency. the system to confirm the market, surveillance
product and inspect ISO Quality System efficacy, safety and quality authorities shall have the
premises; requirements (ISO 13485). after the approval. MHLW power, competence and
• the authority to can assign the devices to be resources:
cancel/suspend the reevaluated on the gazette. • to regularly visit
marketing approval of commercial, industrial
the product; and and storage premises;
• the authority to • to regularly visit, if
mandate a recall of the appropriate, work
product. places and other
premises where
products are put into
service;
• to organise random and
spot checks;
• to take samples of
products, and to subject
them to examination
and testing; and
• to require all necessary
information.
Competent national

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AU CA US JP EU
authorities must take action
to enforce conformity,
when they discover that a
product is not in
compliance with the
provisions of the applicable
directives.
The corrective action
depends on the degree of
non-compliance and, thus,
must be in accordance with
the principle of
proportionality.

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4.3 Market surveillance activities carried out by manufacturers

The TGA may impose In the Medical Devices Surveillance is mainly

“Postmarket Surveillance” Medical Device Directives
certain specific conditions regulations [Section 36 classified in two.
is defined in Title 21 of the (90/385/EEC; 93/42/EEC;
on approval - e.g. that (2)], there is a provision for Food Drug and Cosmetic 1. The surveillance that is 98/79/EC) (Similar
postmaket studies be Health Canada to issue a Act: Sec 522, and enforced prior to approval wording also in ISO EN
conducted, particular medical device license with 21USC360l, [360] (a). of the device. In many 13485): The manufacturer
tracking requirements, etc. conditions. FDA may by require a cases, the post market shall institute and keep up
device manufacturer to surveillance plan is an to date a systematic
ISO 13485, which is cited 36. (2) The Minister may conduct postmarket obligatory condition for procedure to review
in Australian legislation, set out in a medical device approval. This is enforced
surveillance of any class II experience gained from
includes requirements for license terms and when the safety, efficacy
or class III device that devices in the post-
manufacturers or their conditions respecting and the quality of the
meets any of the following production phase and to
representatives to criteria: device could not be implement appropriate
undertake postmarket (a) the tests to be sufficiently demonstrated at means to apply any
surveillance activities to performed on a device to 1) the failure of the device the time of submission for necessary corrective action.
gather experience about ensure that it continues to would be reasonably likely final approval. This type of
product performance and meet the safety and to have serious adverse surveillance is arranged in The requirements of the
safety. Such activities may effectiveness requirements; health consequence; the approval section PMS should be in direct
include: and because the PMS plan is proportion to the risk
• market surveys; 2) the device is intended to considered to be a part of associated with the device.
• product trials; (b) the requirement to be implanted in the human the process of approval. In addition the available
• clinical studies; and submit the results and body for more than one 2. The surveillance scientific knowledge (e.g.
• research & development protocols of any tests year; or performed after the long term effects), market
towards improvement. performed. marketing of the product experience with similar
3) the device is to be used because of adverse events products, and manufacturer
The Medical Devices outside a user facility to or other reasons. The main experience with the product
Bureau would make support or sustain life objective of this type of or technology should be
decisions on which devices surveillance is to re-assess considered (from NB-

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 SG2/N47R4: 2005 Review of Current Requirements on Post-market Surveillance
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to require this extra Manufacturers must
information. simultaneously comply
with FDA medical device
reporting (MDR)
requirements, even during
concurrent 522 data
collection.
May 2005
the safety of the product.
This kind of surveillance is
managed in conjunction
between the approval
section and vigilance
section. This kind of
surveillance is hardly ever
done because the
manufacturer in most cases
prefer to stop the
distribution of the product
rather than be submitted to
the surveillance procedure.
MED/2.12/Rec1, a
guidance document on
Post-marketing
Surveillance systems
published by the European
Coordination of Notified
Bodies Medical Devices).
Manufacturers determine
the extent of the PMS that
is required for their
products. This and its
functioning are checked by
the NB.
Notified Bodies may
request at the time of the
conformity assessment, that
further studies to better
define the safety and
performance of the device
be carried out after placing
the device on the European
market. The Clinical
Evaluation Task Force
(CETF) of the European
Commission is drafting a
guidance document
(MEDDEV) describing
when a post-market clinical
follow-up may be required.
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