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Global Medical Device Regulatory Strategy
Use of Standards in Medical
Device Global Regulatory Strategy
Updated by Susumu Nozawa, RAC, FRAPS
15
Introduction
At the most basic level, standards are docu-
ments providing requirements, specifications,
guidelines and characteristics that can be used
to ensure materials, products, processes and
services consistently are fit for their purpose.
The International Electrotechnical Commission
(IEC) defines “standard” as a:
“Document, established by consensus
and approved by a recognized body, that
provides for common and repeated use,
guidelines or characteristics for activities
or their results, aimed at the achievement
of the optimum degree of order in a given
context.”1
Within the context of medical device develop-
ment, using standards helps provide consistency
in both how a medical device is developed and
the performance and expected results for cer-
tain, typically established, medical device types.
Standards’ compliance may lead to faster regula-
tory approval and, for some countries, compliance
with certain standards is required. Thus, there is
a strategic advantage to understanding standards
and their role in the medical device development
and regulatory approval process.
Navigating standards’ complexity can be
confusing to both medical device development
and approval process newcomers and veterans.
First, there are different types of standards:
process standards and product standards. The
process standards provide guidance on medical
device development and numerous manufactur-
ing and assessment processes. Product standards
generally provide desired results and testing and
assessment means, specific to such factors as the
medical device type, i.e., implantable, and the
materials from which the device is made.
Second, there is no one centralized listing,
database or decision tree to determine the stan-
dards to which a manufacturer needs to conform
for a particular medical device’s development
and regulatory approval. Relevant standards
can vary among regulatory authorities. Many
relevant standards are written specifically for the
medical device industry, while others are written
generically to apply across industries, e.g., ship
testing standards. Such standards are relevant to
both medical device manufacturers and regula-
tors because they provide requirements that can
be used consistently to ensure the device is fit for
its intended use. More frequently used standards
are discussed in this chapter.
Standards are not maintained by one orga-
nization. Many organizations issue standards
used in medical device development and regula-
tory approval. This chapter provides an overview
of the largest standards development and main-
tenance participants. Standards change over
time some are revised, while others become
obsolete and are replaced. Further, since there is
no centralized body issuing standards, it can be
difficult to keep up with the various revisions,
especially in the middle of the product develop-
ment or regulatory submission process.
Another difficulty, in most instances, is
these standards organizations are separate from
regulatory agencies. While regulatory agencies,
such as the US Food and Drug Administration
(FDA), recognize certain standards and stan-
dards’ clauses, this recognition often lags
behind the effective date of new revisions for
certain device classes. Each regulatory agency
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
19
16
20
17
21
18
22
Global Medical Device Regulatory Strategy
Use of Standards in Medical
Device Global Regulatory Strategy
Updated by Susumu Nozawa, RAC, FRAPS
15
Introduction
At the most basic level, standards are docu-
ments providing requirements, specifications,
guidelines and characteristics that can be used
to ensure materials, products, processes and
services consistently are fit for their purpose.
The International Electrotechnical Commission
(IEC) defines “standard” as a:
“Document, established by consensus
and approved by a recognized body, that
provides for common and repeated use,
guidelines or characteristics for activities
or their results, aimed at the achievement
of the optimum degree of order in a given
context.”1
Within the context of medical device develop-
ment, using standards helps provide consistency
in both how a medical device is developed and
the performance and expected results for cer-
tain, typically established, medical device types.
Standards’ compliance may lead to faster regula-
tory approval and, for some countries, compliance
with certain standards is required. Thus, there is
a strategic advantage to understanding standards
and their role in the medical device development
and regulatory approval process.
Navigating standards’ complexity can be
confusing to both medical device development
and approval process newcomers and veterans.
First, there are different types of standards:
process standards and product standards. The
process standards provide guidance on medical
device development and numerous manufactur-
ing and assessment processes. Product standards
generally provide desired results and testing and
assessment means, specific to such factors as the
medical device type, i.e., implantable, and the
materials from which the device is made.
Second, there is no one centralized listing,
database or decision tree to determine the stan-
dards to which a manufacturer needs to conform
for a particular medical device’s development
and regulatory approval. Relevant standards
can vary among regulatory authorities. Many
relevant standards are written specifically for the
medical device industry, while others are written
generically to apply across industries, e.g., ship
testing standards. Such standards are relevant to
both medical device manufacturers and regula-
tors because they provide requirements that can
be used consistently to ensure the device is fit for
its intended use. More frequently used standards
are discussed in this chapter.
Standards are not maintained by one orga-
nization. Many organizations issue standards
used in medical device development and regula-
tory approval. This chapter provides an overview
of the largest standards development and main-
tenance participants. Standards change over
time some are revised, while others become
obsolete and are replaced. Further, since there is
no centralized body issuing standards, it can be
difficult to keep up with the various revisions,
especially in the middle of the product develop-
ment or regulatory submission process.
Another difficulty, in most instances, is
these standards organizations are separate from
regulatory agencies. While regulatory agencies,
such as the US Food and Drug Administration
(FDA), recognize certain standards and stan-
dards’ clauses, this recognition often lags
behind the effective date of new revisions for
certain device classes. Each regulatory agency