Medical Device Qualified Supplier Directory

 

RoHS III and Phthalates: Can Your Contract Manufacturer Support Changing Requirements?

Regulatory changes can have significant impact on product design and market competitiveness. One upcoming example of this impact is the expansion of the European Union’s (EU) list of Restricted or Hazardous Substances, commonly referred to as RoHS 3. The phthalates added to the list are driving a switch from polyvinyl chloride (PVC) to polyurethane (PU) in medical products including tubing, catheters and bags. As with other RoHS directives, regions outside the EU have followed suit in legislation that restricts these substances. And, economies of scale considerations ultimately drive medical device manufacturers to alternatives which are not restricted in any market. This whitepaper looks at the implications of this legislation and ways a contract manufacturing partner can assist in the effort to fully evaluate the range of acceptable alternatives, the cost impact of a change, and efficient development and commercialization of products utilizing the chosen alternative materials.



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