Eucomed explains medtech compliance requirements of RoHS 2

06/13/2013 | MassDevice.com (Boston)

Eucomed has issued guidance for companies that must meet both the requirements of the Medical Devices Directive and the Recast Directive on the Restriction of Hazardous Substances in Electrical and Electronic Equipment, or RoHS 2, to receive CE mark approval. The guidance explains that evaluations of medtech documents and processes regarding conformity with RoHS 2 should be excluded from Notified Body reviews for MDD compliance, since Notified Body assessments aren't stipulated in RoHS 2.

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MassDevice.com (Boston)

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