Guidance Clarifies CA Requirements In Device, Electrical Equipment Laws

Eucomed has released an industry guidance targeting devicemakers that must comply with a law on electrical products in addition to the medical device directive, starting in July 2014. The guidance attempts to differentiate between conformity assessment requirements in RoHS 2 — the amended directive on restriction of hazardous substances in electrical and electronic equipment (2011/65/EU) — and those in the device directive (MDD 93/42/EEC).
International Medical Device Regulatory Monitor