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Global Medical Device Regulatory Strategy
which international standards and editions are
currently accepted and whether backward com-
patibility is accepted.
To summarize, the use of standards to
demonstrate medical device regulation confor-
mity differs among countries. These differences
pose a challenge to the medical device regula-
tory professional in developing a global medical
device regulatory strategy. Fortunately for the
medical device industry, multiple SDOs create
standards deemed to offer the presumption of
conformity to specific regulatory safety and per-
formance requirements, and these documents,
as mentioned earlier, usually are the recognized
standards.3 Manufacturers may rely on docu-
ments published by the International Medical
Device Regulators Forum (IMDRF), which
make multiple normative references to numerous
medical device standards. A later section in this
chapter discusses IMDRF’s work in more detail.
Understanding Standards Numbering
Many regulatory professionals find standards’
versioning or numbering confounding and, when
dealing with standards, the numbering system
indeed can be so. For example, one of the most
well-known standards in the medical device
industry is ISO 13485. An internet search of
“ISO 13485” could yield the following results:
• ISO 13485:2016
• EN ISO 13485:2016
• CAN/CSA-ISO 13485:16
• DS EN ISO 13485:2016
Now, the question is what are the differences?
To answer this question, start with the base
document: ISO 13485:2016. In general, the
structure followed is:
• ISO 13485:2016
o the preceding letters indicate the
issuing organization in this case,
the International Organization for
Standardization (ISO)
o 13485 is the standard number
o 2016 is the revision year, some-
times using only the last two
numbers
Then, the numbering changes as various regu-
latory bodies in different jurisdictions adopt the
standard to meet their specific requirements.
EN ISO 13485:2016 is the version of ISO
13485:2016 adopted by one of the pan-Eu-
ropean standard bodies, CEN, CENELEC
or ETSI. CEN, CENELEC and ETSI are
recognized officially by the EU. Official EU
recognition means these organizations may
adopt European Norms (EN) that can become
candidates for harmonization (recognition) in
Europe under the directives. Appendices were
added to indicate the aspects of the EU Medical
Devices Directive (EU MDD) the standards
satisfy. CAN/CSA-ISO 13485:16 is the ISO
13485:2016 version adopted by the Canada
National Standard/Canadian Standards for
use in Canada. DS/EN ISO 13485:2016 is the
version adopted by Denmark’s Dansk Standards
Association,4 the same version approved by the
European Committee for Standardization as
EN ISO 13485:2016 without any modifications.
While some regulatory jurisdictions
include the year of adoption, some jurisdictions
do not, such as CAN/CSA-ISO 13485:03.
Reviewing the adopted version’s scope is nec-
essary to understand which standard version
was adopted. For example, ISO 13485 was
revised in February 2016, and various standard
bodies went through their adoption process.
There was a three-year transition period for ISO
13485:2016 thus, it is necessary to understand
the revision to which manufacturing organiza-
tions will comply.
Standards Developing Organization
(SDOs)
As defined earlier, an SDO is an organization
dedicated to developing standards. Several
SDOs support the medical device industry
therefore, it is important for a regulatory pro-
fessional to know who they are and understand
why they exist.
An SDO provides consumers, industries
and governments a platform to discuss and
develop international standards. Each SDO,
when appropriate, cooperates with another and
its stakeholders to produce joint publications,
help promote the importance of standardization
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
which international standards and editions are
currently accepted and whether backward com-
patibility is accepted.
To summarize, the use of standards to
demonstrate medical device regulation confor-
mity differs among countries. These differences
pose a challenge to the medical device regula-
tory professional in developing a global medical
device regulatory strategy. Fortunately for the
medical device industry, multiple SDOs create
standards deemed to offer the presumption of
conformity to specific regulatory safety and per-
formance requirements, and these documents,
as mentioned earlier, usually are the recognized
standards.3 Manufacturers may rely on docu-
ments published by the International Medical
Device Regulators Forum (IMDRF), which
make multiple normative references to numerous
medical device standards. A later section in this
chapter discusses IMDRF’s work in more detail.
Understanding Standards Numbering
Many regulatory professionals find standards’
versioning or numbering confounding and, when
dealing with standards, the numbering system
indeed can be so. For example, one of the most
well-known standards in the medical device
industry is ISO 13485. An internet search of
“ISO 13485” could yield the following results:
• ISO 13485:2016
• EN ISO 13485:2016
• CAN/CSA-ISO 13485:16
• DS EN ISO 13485:2016
Now, the question is what are the differences?
To answer this question, start with the base
document: ISO 13485:2016. In general, the
structure followed is:
• ISO 13485:2016
o the preceding letters indicate the
issuing organization in this case,
the International Organization for
Standardization (ISO)
o 13485 is the standard number
o 2016 is the revision year, some-
times using only the last two
numbers
Then, the numbering changes as various regu-
latory bodies in different jurisdictions adopt the
standard to meet their specific requirements.
EN ISO 13485:2016 is the version of ISO
13485:2016 adopted by one of the pan-Eu-
ropean standard bodies, CEN, CENELEC
or ETSI. CEN, CENELEC and ETSI are
recognized officially by the EU. Official EU
recognition means these organizations may
adopt European Norms (EN) that can become
candidates for harmonization (recognition) in
Europe under the directives. Appendices were
added to indicate the aspects of the EU Medical
Devices Directive (EU MDD) the standards
satisfy. CAN/CSA-ISO 13485:16 is the ISO
13485:2016 version adopted by the Canada
National Standard/Canadian Standards for
use in Canada. DS/EN ISO 13485:2016 is the
version adopted by Denmark’s Dansk Standards
Association,4 the same version approved by the
European Committee for Standardization as
EN ISO 13485:2016 without any modifications.
While some regulatory jurisdictions
include the year of adoption, some jurisdictions
do not, such as CAN/CSA-ISO 13485:03.
Reviewing the adopted version’s scope is nec-
essary to understand which standard version
was adopted. For example, ISO 13485 was
revised in February 2016, and various standard
bodies went through their adoption process.
There was a three-year transition period for ISO
13485:2016 thus, it is necessary to understand
the revision to which manufacturing organiza-
tions will comply.
Standards Developing Organization
(SDOs)
As defined earlier, an SDO is an organization
dedicated to developing standards. Several
SDOs support the medical device industry
therefore, it is important for a regulatory pro-
fessional to know who they are and understand
why they exist.
An SDO provides consumers, industries
and governments a platform to discuss and
develop international standards. Each SDO,
when appropriate, cooperates with another and
its stakeholders to produce joint publications,
help promote the importance of standardization