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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

consumers and indicates conformity with the “basic

safety requirements” set out in European Directives

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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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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

of medical devices in all phases of the product’s lifecycle.

(ISO 14971, 3.1, NOTE 2 state …Depending on the

specific life-cycle phase, individual elements of risk

management can have varying emphasis…)

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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An analysis was made regarding the definition of “public

health threat” in the MEDDEV and GHTF documents and it

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 “Good Clinical Practices (GCP)

principles” has been added.

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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” as

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;

supporting information specified … is submitted; and

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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DIN overview

Standardization

First steps to revise ISO 14155

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

ISO’s national members. If you are interested in getting

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: karl.wenzelewski@din.de

DIN German Institute

for Standardization

Thank you for your attention!