218
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
may recognize different standards or different
standards’ revisions, thus the list of standards
to which a manufacturer must adhere varies
among jurisdictions. If a product is intended for
multiple jurisdictions, regulatory professionals
should start by researching common and similar
requirements simultaneously applicable to each.
To meet regulatory expectations, stan-
dards are not standalone documents, may be
referenced or accepted by various regulatory
authorities around the world and must be
viewed in parallel with local regulations. An
entity dedicated to creating standards is called
a standards development organization (SDO).
Standards developed by an SDO are intended to
be voluntary and, as such, do not aim to replace
local regulations. This is the reason certain regu-
latory authorities may determine standards will
be mandatory in their jurisdictions this type
of determination, however, is uncommon. On
certain occasions, for certain jurisdictions, even a
widely used standard may not address a medical
device’s safety and performance concerns ade-
quately. An example of this is FDA’s Guidance on
Radio Frequency Wireless Technology in Medical
Devices.2 This guidance states the IEC 60601-
1-2 consensus standard did not address wireless
technology electromagnetic compatibility
(EMC) adequately at the time the final guidance
was issued in August 2013. A manufacturer
intending to seek market approval in multiple
jurisdictions should consult international stan-
dards and local regulations in parallel.
In the US, a ‘consensus standard’ is one
developed by an SDO using the consensus
developing process, while a ‘recognized consen-
sus standard’ is a standard FDA has evaluated
and recognized for use and published in the
Federal Register. The consensus developing
process is described later in this chapter. If a
manufacturer chooses not to comply with cer-
tain sections of a recognized consensus standard
when compliance with the standard is expected
(i.e., if the standard is referenced within an
FDA guidance document), the regulatory sub-
mission should justify the deviation and provide
the alternative used. A manufacturer must
understand the risks it takes by not complying
with applicable standards. If a manufacturer
wishes to use a national standard of a country
other than the US for US market clearance or
approval, it may discuss the plans with FDA
in the presubmission process. In contrast, the
EU Medical Devices Regulation (EU MDR) and
directives in other industrial sectors, rely on
“harmonized” European Norms (EN) or stan-
dards. Those standards are prepared in response
to a mandate from the European Commission
(EC). They are intended to be used to demon-
strate conformity to the essential requirements
in one or more directives and are developed
by the European standardization bodies, the
European Committee for Standardization
(CEN), European Committee for
Electrotechnical Standardization (CENELEC)
or European Telecommunications Standards
Institute (ETSI). Notices on the standards are
published in the EU Official Journal. Use of
these voluntary standards confers a presumption
of conformity with the directives’ mandatory
regulatory requirements.
In Australia and some countries in Asia
and South America, the extent to which a
standard is accepted or recognized may vary
by local law. For example, in China, foreign
manufacturers may submit a notarized quality
system certificate of compliance to a standard,
such as ISO 13485 Medical Devices—Quality
Management Systems—Requirements for
Regulatory Purposes or FDA’s Quality System
Regulation (QSR), to the China’s National
Medical Products Administration (NMPA).
It is possible the Chinese version lags behind
the international version. In this case, the
manufacturer has to demonstrate compliance
with the Chinese standard and provide the
necessary test reports. IEC 60601-1 second and
third editions may serve as another example a
manufacturer would need to meet second edi-
tion test report requirements in China, while
in much of the rest of the world, it would in
fact meet third edition test reports. The Brazil
Good Manufacturing Practice (BGMP) is
similar to ISO 13485 per Brazilian Resolution
RDC 185/2001 therefore, a certificate of com-
pliance to ISO 13485 may be acceptable. It is
important for regulatory professionals to consult
with local regulatory agencies to understand
Chapter 15: Use of Standards in Medical Device Global Regulatory Strategy
may recognize different standards or different
standards’ revisions, thus the list of standards
to which a manufacturer must adhere varies
among jurisdictions. If a product is intended for
multiple jurisdictions, regulatory professionals
should start by researching common and similar
requirements simultaneously applicable to each.
To meet regulatory expectations, stan-
dards are not standalone documents, may be
referenced or accepted by various regulatory
authorities around the world and must be
viewed in parallel with local regulations. An
entity dedicated to creating standards is called
a standards development organization (SDO).
Standards developed by an SDO are intended to
be voluntary and, as such, do not aim to replace
local regulations. This is the reason certain regu-
latory authorities may determine standards will
be mandatory in their jurisdictions this type
of determination, however, is uncommon. On
certain occasions, for certain jurisdictions, even a
widely used standard may not address a medical
device’s safety and performance concerns ade-
quately. An example of this is FDA’s Guidance on
Radio Frequency Wireless Technology in Medical
Devices.2 This guidance states the IEC 60601-
1-2 consensus standard did not address wireless
technology electromagnetic compatibility
(EMC) adequately at the time the final guidance
was issued in August 2013. A manufacturer
intending to seek market approval in multiple
jurisdictions should consult international stan-
dards and local regulations in parallel.
In the US, a ‘consensus standard’ is one
developed by an SDO using the consensus
developing process, while a ‘recognized consen-
sus standard’ is a standard FDA has evaluated
and recognized for use and published in the
Federal Register. The consensus developing
process is described later in this chapter. If a
manufacturer chooses not to comply with cer-
tain sections of a recognized consensus standard
when compliance with the standard is expected
(i.e., if the standard is referenced within an
FDA guidance document), the regulatory sub-
mission should justify the deviation and provide
the alternative used. A manufacturer must
understand the risks it takes by not complying
with applicable standards. If a manufacturer
wishes to use a national standard of a country
other than the US for US market clearance or
approval, it may discuss the plans with FDA
in the presubmission process. In contrast, the
EU Medical Devices Regulation (EU MDR) and
directives in other industrial sectors, rely on
“harmonized” European Norms (EN) or stan-
dards. Those standards are prepared in response
to a mandate from the European Commission
(EC). They are intended to be used to demon-
strate conformity to the essential requirements
in one or more directives and are developed
by the European standardization bodies, the
European Committee for Standardization
(CEN), European Committee for
Electrotechnical Standardization (CENELEC)
or European Telecommunications Standards
Institute (ETSI). Notices on the standards are
published in the EU Official Journal. Use of
these voluntary standards confers a presumption
of conformity with the directives’ mandatory
regulatory requirements.
In Australia and some countries in Asia
and South America, the extent to which a
standard is accepted or recognized may vary
by local law. For example, in China, foreign
manufacturers may submit a notarized quality
system certificate of compliance to a standard,
such as ISO 13485 Medical Devices—Quality
Management Systems—Requirements for
Regulatory Purposes or FDA’s Quality System
Regulation (QSR), to the China’s National
Medical Products Administration (NMPA).
It is possible the Chinese version lags behind
the international version. In this case, the
manufacturer has to demonstrate compliance
with the Chinese standard and provide the
necessary test reports. IEC 60601-1 second and
third editions may serve as another example a
manufacturer would need to meet second edi-
tion test report requirements in China, while
in much of the rest of the world, it would in
fact meet third edition test reports. The Brazil
Good Manufacturing Practice (BGMP) is
similar to ISO 13485 per Brazilian Resolution
RDC 185/2001 therefore, a certificate of com-
pliance to ISO 13485 may be acceptable. It is
important for regulatory professionals to consult
with local regulatory agencies to understand