European product safety, liability and single – Use devices in a medical context

Abstract:

In this paper, the author examines some European initiatives to increase product safety. Given the rapid evolution and increased complexity of technology, the absence of scientific certainty about harmful effects of certain applications or products is no longer an acceptable motive for delaying protective action.

On the contrary, today we can no longer speak about safety regulations without mentioning the precautionary principle. Besides, in innovative, highly technical fields the regulator cannot rule everything. They cannot guarantee the safety of products and services without the help of the field itself.

Following the new European approach of harmonisation, an important part of the regulatory process is left to private-law organisations.