Quality First International

Comparison of Product Safety Requirements of the Medical Devices and Toys Directives

It is an interesting curio that European legislation to protect users and permit free movement of trade across the Community was enacted for toys before medical devices. Perhaps formulation of legislation was simpler or less contentious for toys; there simply may have been no reason whatsoever, nevertheless certain parallels about particular elements of Council Directives 88/378/EEC (concerning toys) and 94/42/EEC (medical devices) reveal an intriguing insight into the respective controls considered necessary for the two industries. This white paper compares and contrasts selected elements of the Directives, questioning whether the obligations for medical devices are rational and commensurate. Lessons from recent, topical post-market examples are considered.

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