eurobit & a global product approval system for the future
TRANSCRIPT
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