In response to the recent MRA Bulletin (text provided at the end of this message),
For those of you who would like a bit more of a clarification on this, I offer the following: - The United States and Canada have reached an Agreement with the European Union for establishing a regulatory structure to support a mutual acceptance of product approvals. The Agreement is expected to be initialed this week. What does this mean? . CE Marking requirements will continue to be fully enforced. . MRAs will provide the mechanism for U.S. organizations to be appointed 3rd party approval authorities for CE Marking in the following sectors: Electrical Safety, EMC, Medical Devices and Pharmaceuticals, Telecom, and Recreational/Leisure Craft. . It will take a minimum of one year for the agreement to be approved by the member countries of the European Union for implementation. Only when the agreement has been implemented, will a treaty go into force. This bulletin will be followed with more specific details. A MRA Update section will be added to our web site at http://www.TechIntl.com. Updates will also be provided via email if an email address is provided to us. -----And Furthermore----- After implementation has begun the listed product sectors will have following transition periods: Electrical Safety will be "fully operational" right away. Telecom and EMC will have a 24 month transition period Medical and Pharmaceutical GMPs will have a 36 month transition period Recreational and leisure craft will have a 18 month transition period This Agreement must be approved by the World trade Organization (WTO) Likely: Impact: No change in regulatory compliance process for 12 months. The regulatory structure is still to be developed in the United States. The new system will likely have a lead Government agency (probably NIST). Existing regulatory compliance providers will likely have a major impact in the actual process. Best plan: Continue with existing CE Marking compliance plans. Establish a regular communication with EU compliance resources for latest details on emerging system. Continue to meet domestic compliance requirements. Comments: Since it's going to take all 15 member states to accept this, look forward to a bureaucratic nightmare, and the possibilities of real delays, especially in the Telecom area where all of our favorite destination countries are controlled by state-owned monopolies. Personally, I look forward to it. I think it will certainly level the playing field and get all of these bottle-neck agencies to compete a bit more effectively. In addition, we should all see our costs of doing business in the regulatory environment come down. At the risk of advertising for a company by whom I will no longer be employed in a week from now, check out the website mentioned above for up-to-the minute details. The CEO has an in with the Commerce Department Best regards. Rick Towner, soon-to-be regulatory compliance manager, Comdisco Corporation, CEG division. same bat place, same bat channel. P.S. Nice poem, Dave. _________________________________________________________ U.S., EU Reach Agreement on Mutual Recognition of Product Testing & Approval Requirements Agreements cover $50 billion in two-way trade U.S. Department of Commerce News Release from the Office of the Secretary, Friday, June 13, 1997 Washington-- The United States and European Union have agreed to a package of mutual recognition agreements (MRAs) that will reduce trade barriers in six industry sectors covering approximately $50 billion two-way trade, U.S. Commerce Secretary William M. Daley and U.S. Trade Representative Charlene Barshefsky announced. When fully implemented, the agreements willrecognize the results of product testing or certification requirements set by both governments and eliminates the need for duplicative testing, inspection, or certification requirements for products from each side of the Atlantic. "Under this landmark agreement U.S. regulatory agencies, for the first time, have entered into a cooperative international agreement that strives to reduce regulatory costs while at the same time seeks to expand market access and protect the health and safety of consumers on both sides of the Atlantic," Commerce Secretary Daley said. "Completion of these mutual recognition agreements has been a longstanding priority of the United States and the European Union," Secretary Daley added. "I also want to give credit to the Transatlantic Business Dialogue. The TABD and the MRA was important; we heard them and acted." "We achieved an agreement that is good for U.S. and EU business, good for our regulatory agencies, and good for our consumers," said Barshefsky. "The MRA is yet another example of the Administration's push to open markets in sectoral areas where the United States leads the world, while assuring our absolute right to choose our own health and safety standards. The real winners today are manufacturers, workers, and consumers, both in America and in Europe, who will see reduced costs, increased jobs, and a better standard of living." These agreements are expected to increase U.S. exports by saving manufacturers more than $1 billion in costs annually, which is equivalent to a two or three point reduction in tariffs. The MRAs include telecommunications, medical devices, electromagnetic compatibility, electrical safety, recreational craft, and pharmaceuticals. The agreements allow products or processes to be assessed for conformity (i.e., testing, inspection, and certification) in the United States to European Union standards, and vice versa. After entry into force, the agreements will be phased in and fully implemented in two years for electronic products and three years for health products. This agreement was concluded with the support of the Transatlantic Business Dialogue (TABD), a U.S.-EU government-business partnership that generates business recommendations for removing barriers to transatlantic trade for direct consideration in the government decision-making process.
