European and US quality system requirements for packaging
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- PMID: 10167684
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European and US quality system requirements for packaging
Med Device Technol.
1997 May.
Abstract
The packaging of medical devices bearing the CE mark must comply with the European Directives for medical devices. Packaging of medical devices marketed in the United States (US) must meet US requirements. Although these requirements are more stringent for sterile products, they apply to sterile and non-sterile products. This article will discuss the requirements, US guidance for complying with them, and some of the international and European standards for packaging that are available or being prepared.
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