CE Marking overview. CE Marking overview Access to the Market of Your Choice. 1 25/09/2012 Presentation TÜV Rheinland

Transcription

1 CE Marking overview CE Marking overview Access to the Market of Your Choice 1 25/09/2012 Presentation TÜV Rheinland

2 Global Market Conditions Export opportunities offer additional revenue, but what s involved? Meeting operational deadlines Understanding and meeting market access requirements Managing costs 2 25/09/2012 Presentation TÜV Rheinland

3 International Approvals Entering Tier 1 Countries - US, Canada, EU, Japan Entering Tier 2 Markets - - Brazil South Africa - Russia Argentina - India Saudi Arabia - China Australia - Korea Mexico 3 25/09/2012 Presentation TÜV Rheinland

4 OK, so what is CE anyway.. Although sometimes said to be an acronym for Confusion Everywhere, CE is the legally required method of showing a product s conformance with the required Directives Directives are EU requirements designed to govern free trade in the EU Instead of needing to meet separate requirements for Britain, Germany, France, Italy etc., Directives establish a single set of requirements for products being sold in the EU 4 25/09/2012 Presentation TÜV Rheinland

5 A little more detail.. CE is a New Approach method designed to facilitate free trade. Before CE, each country had their own labs for issuance of country-specific approval Marks. Many labs were government owned, and obtaining approvals was time-consuming CE does not require a test lab be used, but by law, the manufacturer assumes all risk and liability associated with the product s conformity to the CE requirements The statement made by the manufacturer is the CE Mark on the product and the one page Declaration of Conformity. These must be supported by a Technical File. The details of the contents of a Technical File can be found in the particular Directives. One of the most important elements of the Technical File is the product test report 5 25/09/2012 Presentation TÜV Rheinland

6 So, who provides CE Approval? No entity or agency provides the approval CE approval is Self Declared by the manufacturer 6 25/09/2012 Presentation TÜV Rheinland

7 What does Self Declared mean? A common misconception - manufacturers can just apply a sticker that says CE. Like most things, if it seems to good to be true it probably is A corporate officer is required to sign a Declaration of Conformity (DoC), which must include: manufacturer's details, essential characteristics the product complies, any European standards and performance data, if relevant the identification number of the Notified Body, and a legally binding signature on behalf of the organization. 7 25/09/2012 Presentation TÜV Rheinland

8 Test report issued from a lab Three options for creating test reports exist 1. Self testing by the manufacturer 2. Using a small/local lab 3. Using an agency lab with a global footprint 8 25/09/2012 Presentation TÜV Rheinland

9 How is CE enforced? Customs agents - Proof of a CE Mark and a Declaration of Conformity is verified at customs The sales world - Distributors and/or resellers typically require these items before receiving the product Consumers: European consumers actually demand proof of CE before they will place the order for the product Result of an incident - government authorities become involved and will demand to see the Technical File, focusing on the test reports. Reports from an accredited lab support a DoC and indicate the product was tested properly 9 25/09/2012 Presentation TÜV Rheinland

10 How is CE enforced? Independent testing - Some companies purchase competitors products and have independent lab testing performed against applicable standards. If problems are found, authorities are alerted. Problems are typically not because the manufacturer tried to cheat the regulations, but rather because manufacturers don t understand them. Despite this, products may be removed from the EU market, and units in the field recalled 10 25/09/2012 Presentation TÜV Rheinland

11 Questions? Who? What? How? Where? 11 25/09/2012 Presentation TÜV Rheinland

12 Global Reach - The TUV Rheinland Worldwide Network 375+ locations, 65 countries, 12,500 people.. At your service! 12 25/09/2012 Presentation TÜV Rheinland