eurobit & a global product approval system for the future

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEM

FOR THE FUTURE

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

A GLOBAL MARKET PLACE Needs

• harmonized approval regime• horizontal legislation• recognition of SDoC• harmonized requirements• simplified marking

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

PRESENT SITUATION To reach a global market place one must consider

• horizontal and sectoral legislation• various means of showing compliance• marking and user information• role of test houses

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

HORIZONTAL LEGISLATION

• for convergence of technologies

• for multifunctional products

• reliance on competition and consumer

protection laws

eurobit &

SECTORAL LEGISLATION

• limited for specific aspects

• deregulate as far as possible

• enable one-stop shopping

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

DIFFERENT WAYS TO FUTURE COMPLIANCE

Preferred route• SDoC without mandatory third party involvement

As a contrast to• National approval• Global type approval

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

MARKING & TEST HOUSES

• single mark

• increased need to inform the user

• placing on the market - right to use

• voluntary verification system

• test houses as “insurance companies”

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

PROPOSAL FOR WTO:

Conformity Assessment Agreement (CAA)

Global agreement on a system for ConformityAssessment, based on

• Suppliers Declaration of Conformity

• Market surveillance by National Authorities

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

THE NEXT STEPS

• different starting points in

different regions

• discussions on regional level

on how to adapt to the future

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

THE WAY FORWARD

• Global system based on fair and simple rules

• Suitable also for developing countries

• Horizontal legislation wherever possible

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

THE WAY FORWARD (cont)

• Use of SDoC without mandatory third party

intervention

• De-regulate as far as possible

• Use of voluntary system corresponding to

market needs

eurobit &

A GLOBAL PRODUCT APPROVAL SYSTEMFOR THE FUTURE

WEBSITE Information

• ECTEL: www.ectel.org

• EUROBIT: www.fvit-eurobit.de