THE APPLICATION OF THE 'NEW DIRECTIVE' MANAGING CHANGE

摘要

Change is an evolutionary constant that effects everyone to some degree. Our ability to adapt and identify positive characteristics within any change, is a key element to our future survival. How well we can adapt to change will be the true measure of our success. At the 1996 NCSL conference there was a significant amount of interest with the concept of the European "New Approach" a single market place with uniform regulations. Many US companies did not feel that this "New Approach" was of any significance based on Europe's inability to unify. Accordingly they did not move forward in adapting to the changing environment. The new regulations primarily identify improvements in the health, safety and environmental requirements placed on manufactured products. Companies providing only services were not specifically identified as having any unique requirements since they did not effect the design of the product but no exemptions were provided under the directives. As such, all the requirements that are placed on the manufactures also are imposed on the providers of services. Several US organizations have adopted the "CE" initiative, the FDA as one, now requires the "CE" mark to be placed on new medical equipment.