MD+DI DeviceTalk: REACH Updates and a Comparison to RoHS

The March 23, 201 online edition of MD+DI DeviceTalk features REACH Updates and a Comparison to RoHS by StarFish Medical Mechanical Engineer Nigel Syrotuck.

Syrotuck discusses and compares the February 2017 European Chemical Agency (ECHA) draft guidance on requirements for substances in articles under REACH (Registration, Evaluation, Authorization, Restriction of Chemicals, Regulation (EC) No 1907/2006) the European RoHS (Restriction of the use of certain Hazardous Substances, Directive 2011/65/E) directive. Syrotuck interprets the guidance from the point of view of a finished goods manufacturer/ importer, specifically for medical devices, who has a solid understanding of RoHS.

After noting that “…meeting its requirements is a must to sell products in Europe.meeting its requirements is a must to sell products in Europe,” in the beginning of the article, Syrotuck concludes the article with this piece of advice, ” I’d highly recommend planning to spend a significant amount of time understanding your requirements under REACH and defining your plan to comply with it and RoHS 3 if you want to sell your product in the European Market.”



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