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DIN
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Quo vadis
The next steps for the revision of ISO 14155
Karl Wenzelewski Projectmanager
Optics and Precision Mechanics Standards Committee (NAFuO)
DIN German Institute for Standardization
Aussenstelle Pforzheim
Summer Academy on Medical Technology
23rd September 2014
IHK Lübeck
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DIN overview
Standardization
First steps to revise ISO 14155
Outlook on further topics to be revised
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DIN German Institute for Standardization
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is a registered non-profit
association supported by the
private sector.
On the basis of a contractual
agreement with the Federal
Republic of Germany, DIN is
the responsible German
standards body in European
and international standards
work.
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DIN is a service provider
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DIN functions as a "round table" and increasingly as an electronic
platform where stakeholders can develop modern consensus-
based standards suited to market needs
DIN
organizes the entire
standardization process
at national level and
German participation in
European and international
standards work
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Democratic legitimation of standardization depends on the
involvement of all stakeholders
Standardization in joint responsibility
User
Work safety
Trade unions
Public
authorities
Test institutes
Environment
protection
Consumer protection
Economy
Science and
research
Regulatory
institutions
STANDARDIZATION
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DIN overview
Standardization
First steps to revise ISO 14155
Outlook on further topics to be revised
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What is a standard?
Definition:
"document, established by consensus and approved by a
recognized body, that provides, for common and repeated use,
rules, guidelines or characteristics for activities or their results,
aimed at the achievement of the optimum degree of order in a
given context".
A technical standard represents the state of technology as
determined in a consensus-based process.
Standards lay down general and/or detailed specifications for
products, procedures and services alike.
A standard is a recommendation whose use is voluntary.
Standards are only legally binding if they are part of a
contractual agreement between parties, or if legislators
stipulate conformity with them
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Standardization helps to identify shared problems
helps to find solutions together with experts
gives an international platform for discussions
helps to consolidate definitions
helps to converge
Participation in standards work
Technical expertise
Provided by experts representing stakeholders
Authorized as delegates in technical committees
Member of working groups
Balanced representation of stakeholder groups
Good reasons to get involved!
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Involvement in European and International
Standards Committees
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Technical
Committee
Working
Group
Delegates
Experts
ISO CEN
DIN
ANSI
Mirror
committee
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Cooperation between International and European standards
bodies: Vienna and Dresden Agreements
Objective:
where possible, carry out specialist work at one level of
standardization, and use parallel voting procedures to achieve
simultaneous adoption as ISO/IEC and EN Standards
Vienna
Agreement
Dresden
Agreement
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Global relevance
Objective: Development of uniform international standards, which are accepted worldwide
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Involve many member countries in standards work
Involve all stakeholders
Prevent national variations
Give priority to describing performance requirements
and interfaces
No standardization of products
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Components of the New Approach
EC Directive
European Directives set out basic requirements for
specific sectors
"Harmonized" European Standards
Harmonized European Standards give substance to
these basic requirements and provide technical
solutions
Essential requirements
Implementation of harmonized European Standards
implies conformity with European Directives
CE marking
The mark is addressed to public authorities, not to
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Mandated European Standard EN /EN ISO
A European Standard, developed and applied in the
context of the New Approach, and developed on the
basis of a mandate from the European Commission.
Developed like a "normal" EN
No special designation, except for a note in the
Foreword
Must include an additional informative annex, referring to
the relevant EU Directive
Mandated standards must be announced with number
and title in the EU Official Journal
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First steps to revise ISO 14155
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DIN overview
Standardization
First steps to revise ISO 14155
Already included
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ISO 14155 and the application of ISO 14971
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ISO 14155
How risk
management
activities
relate to
ISO 14155
ISO 14971
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ISO 14155 and the application of ISO 14971
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ISO 14971, which is a normative reference to ISO 14155,
is a general standard describing how to manage the risk
specific life-cycle phase, individual elements of risk
ISO 14971 describes methods of identification for design,
manufacture and use risks and requires surveillance on
post-production risks.
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Risk management in clincal evaluation
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How is
risk/benefit
addressed?
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Risk management in clincal evaluation
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Analysis of ISO 14155
References to risk management
5.2 Risk Evaluation (from Clinical Investigation Planning)
5.11 Data Monitoring Committee (from Clinical
Investigation Planning)
8.2.5 Safety evaluation and reporting (from
Sponsor Responsibilities)
A4. Risks and benefits of the investigational
device and clinical investigation (from Annex A,
Clinical Investigation Plan)
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Risk management in clincal evaluation
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The analysis showed that there is nothing wrong with the
wording on risk evaluation in ISO 14155, however
people may have difficulties in understanding how
risk management activities fit into ISO 14155 and
also, literature review is identified as an important
part of risk analysis for clinical studies.
ISO 14971 does not contain requirements or guidance
specific to risk management in the pre-market phase.
Instead, it falls to ISO 14155 to provide any such
requirements or guidance.
Thus a flowchart has been included for discussion, which
shows the inter-relationship of information on risk and
indicates where it is necessary to include such informa-
tion in study documents.
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Definitions
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was agreed to include a definition.
In addition, it was agreed on the following:
To add some explanations in 6.4.3, 7.1.1 and 8.2.5,
and A.14.
To add this to the flowchart in annex F
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Good clinical practice List of principles
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In contrast to ISO 14155, ICH 6 covered the principles
of GCP in one section. It was requested by the Asian
countries, to include a single clause listing the principles
of GCP, which makes it easier for national regulatory
authorities to refer to the GCP principles.
A new Clause 4
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Study registration in public database
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Study registration in public database
Is an important point because it is becoming part
of the regulation.
In the US it is already mandatory that it is in the
informed consent.
There is a NOTE in the ISO 14155, 7.3, NOTE 2.
It was agreed to include a new subclause
Registration in public accessible database
well as to include the requirements in several
other clauses/subclauses
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Ethic Committee (EC) responsibilities
Clinical studies conducted outside the USA
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US FDA is proposing to address requirements for US FDA
acceptance of data from non-US clinical studies, which
indicates that US FDA will accept such data if:
they are valid;
two statements are provided,
one asserting that all such studies have been
conducted in accordance with GCP,
the other ensuring availability of the data from the
study to US FDA for validation via onsite
inspections or other appropriate means.
This new requirements lead to the inclusion of a new Annex G
Ethics Committee (EC) responsibilities
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Next steps to revise ISO 14155
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DIN overview
Standardization
First steps to revise ISO 14155
Next steps to revise ISO 14155
Outlook for further discussion
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Next steps to revise ISO 14155
Outlook for further discussion
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Debarment of Clinical Investigators Elaborate on conflict of interest, compensation review by
Authorities
Study design Better to specify in the protocol in Annex A?
Weak points with regard to Annex A review To be combined with study design
Adapt ISO for registries Prepare a proposal for ISO integration /clarification on post-
market surveillance, studies and registries.
Electronic records/data privacy To do a side by side gap analysis of ICH E6 versus ISO
14155
Better link to ISO 13485 & Usability standard
Outline on Annex for inspections/audit
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Take part in standardization
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Next meeting of ISO/TC 194/WG 4
The next meeting of ISO/TC 194/WG 4 is scheduled for
October 28th and 29th 2014
Arlington, Virginia, USA
How to get involved?
Standards are developed by groups of experts called
technical committees. These experts are put forward by
involved, contact your national member.
Contact details can be found in the list of ISO members.
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Useful links
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DIN Homepage
NAFuO Homepage
CEN/CENELEC Homepage
List of CEN Members
ISO Homepage
List of ISO members
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Karl Wenzelewski
Project manager
Optics and Precision Mechanics
Standards Committee (NAFuO) Aussenstelle Pforzheim
Alexander-Wellendorff-Str. 2
75172 Pforzheim
www.nafuo.din.de
www.din.de Phone: +49 7231 9188 -24
Fax: +49 7231 9188 -33
E-Mail: [email protected]
DIN German Institute
for Standardization
Thank you for your attention!
