Medical device makers face new obstacles to European approval

Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.  The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval. The new Restriction of Hazardous Substances (RoHS-2) document became law in July 2011 and took effect last year. The original RoHS rules exempted all medical devices, allowing them to contain unspecified amounts of materials deemed otherwise toxic.

RoHS-2 now only fully exempts “active implantable medical devices,” bringing materials used in in vitro diagnostics and other medical devices under regulatory oversight.

The RoHS-2 regulations took effect on July 21, 2011, but restrictions have been scheduled to phase in over several years. The medical device rules took effect in July 2014 and restrictions for in vitro diagnostics will take effect in 2016. The revisions will apply to all non-excluded electrical and electronic equipment in 2019.

REFERENCE: Mass Device; 30 JUL 2014; Arezu Sarvestani

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