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Entries in CE Mark (1)

Friday
Jul222011

RoHS Directive now applies to Medical Devices

The European Restriction of Hazardous Substances (RoHS) directive has been updated by release of Directive 2011/65/EU. The Directive now includes medical devices and IVDs (except for active implants) within its scope. The Directive mandates Technical Files, records retention and traceability information.

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