1. Harmonizing Technical Standards for CE marking and the European Union James W. Kolka Ph.D., J.D. President Kolka & Associates LLP Back to Outreach page

2. European Commission White Paper-March, 1985  Key technical statement from the EU commission  Contained 300 pieces of legislation (reduced to 286 ) Back to Outreach page

3. White Paper pledged to eliminate fiscal, technical and physical barriers  Replace national standards with EU standards  Eliminate national regulations that restrict trade  Agree on EU wide certification and test procedures Back to Outreach page

4. EU created new approach directives  Create a framework for compliance and conformity assessment  Identify essential safety requirements  Create EN harmonized standards to implement the directive  Create both safety and quality requirements Back to Outreach page

5. New approach directives(cont.)  Multiple EN harmonized standards have been created to implement each directive  Example- Machinery Safety Directive contains approximately 1000 standards for implementation  EU Medical Devices Directives are being harmonized with the FDA Back to Outreach page

6. New approach directives (cont.)  CE marking is a legal requirement for all products affected by new approach directives  The operative language is “placing on the market”  Unmarked or illegally marked products are subject to civil fines and criminal sanctions Back to Outreach page

7. New approach directives (cont.)  Compliance with directive requirements means market entry throughout the EU  Compliance is not a casual response-it will require time, money and effort  Other countries are adopting EU approaches to product safety Back to Outreach page

8. Products affected by EU new approach directives  Toys, Construction Products, Telecommunications Equipment, Machinery, Active Implantable Medical Devices, Medical Devices, In Vitro Diagnostic Medical Devices, Personal Protective Equipment, Hot Water Boilers Fired with Liquid and Gaseous Fuels, Appliances Burning Gaseous Fuels Back to Outreach page

9. Products (cont.)  Simple Pressure Vessels, Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres, Recreational Craft, Lifts, Non-Automatic Weighing Instruments, Marine Equipment, Cableway Installations Designed to Carry Passengers, Pressure Equipment, Low Voltage, Electromagnetic Compatibility Back to Outreach page

10. EU Approach to Product Safety  Will affect substantial number of products in world trade  Directives and standards requirements apply to all manufacturers (US&EU) who wish to do business in the European Union  Several countries are adopting the EU approach Back to Outreach page