Packaging Legislation & Regulation for Medical Devices by Pira International Ltd
By Pira International Ltd
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Additional resources for Packaging Legislation & Regulation for Medical Devices
Sample text
The labelling of a medical device and its packaging are interrelated. It is not possible to start designing the packaging of a device after it is labelled. Hence the information in this report relates to labelling as an essential part of packaging. The FDA has reported an increase in deaths associated with apparent sensitivity to latex proteins contained in packaging of medical devices. Its initial directive was on deaths caused by barium enema procedures that were associated with anaphylactic reactions with a natural rubber cuff used on the tip of the barium enema catheters.
The necessary measures shall form part of a policy covering all packaging and packaging waste and shall take into account, in particular, requirements regarding the protection of environmental and consumer health, safety and hygiene, the protection of quality, the authenticity and the technical characteristics of the packed goods and materials used as well as the protection of industrial and commercial property rights. Essential requirements EU member states should ensure that three years from date when this directive comes in to force, all packaging might be placed in the market only if it complies with the essential requirement given by this directive.
Member states shall inform the commission of this. The commission shall confirm these measures, after having verified, in cooperation with the member states, that they are consistent with the considerations above and do not constitute an arbitrary means of discrimination or a disguised restriction on trade between member states. Return, collection and recovery ᮣ Member states shall take the necessary measures to ensure that systems are set up to provide for these items: ᮣ Page 38 The return and collection of used packaging and packaging waste from the © Copyright Pira International Ltd 2006 Packaging Legislation and Regulations for Medical Devices Europe 6 consumer, other final user, or from the waste stream in order to channel it to the most appropriate waste management alternatives.