1. POINT/COUNTER.
- Author
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Rosen, Emanuel S. and Nardi, Marco
- Subjects
- *
SURGICAL equipment - Abstract
The article presents answers to a question on whether the CE mark approval process should be more rigorous. Ophthalmologist Emanuel S. Rosen agrees that the CE mark is a stamp of safety issues in the production method but not on the efficacy and that the need for a U.S. Food and Drug Administration (FDA) approval would complicate matters. Dr. Marco Nardi believes that the CE mark warranties conformity but sees the need for European surgical devices to have rigorous regulations in Europe.
- Published
- 2009