EU RoHS - In Vitro Diagnostic Equipment

Question Posed:

Could you tell me if an In Vitro Diagnostic Reagent without any equipment is compliant with EU RoHS?

Answer Provided:

EU RoHS (2011/65/EU) only applies to EEE which is defined as ‘electrical and electronic equipment’ or ‘EEE’ means equipment which is dependent on electric currents or electromagnetic fields in order to work properly and equipment for the generation, transfer and measurement of such currents and fields and designed for use with a voltage rating not exceeding 1 000 volts for alternating current and 1 500 volts for direct current.

If your reagents don't use any equipment that meets the above definition, then it is not in scope of EU RoHS and would not need to comply.  However, if the reagent uses any equipment that meets the definition of EEE, then you need to comply because In vitro medical devices came into scope July 22, 2016.

Reference: http://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32011L0065 Article 3 (1)

**Article contents valid as of 2017-06-21

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