title: European and US quality system requirements for packaging.
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.
authors.affiliation: Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D004864:Equipment and Supplies; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D019064:Product Packaging / Q000331:legislation & jurisprudence* / Q000592:standards*; D011786:Quality Control; D013242:Sterilization; D014481:United States