French invoke Safeguard clause for condoms
This article was originally published in Clinica
Executive Summary
Condoms may only be marketed in France if they are subject to batch control by a Notified Body under the Medical Devices Directive, according to French condom standard NF S 97-031. In publishing its decree, the French government is the first to make use of the Medical Devices Directive's Safeguard clause - on the grounds of inadequate standards. The European Commission is currently reviewing the situation.
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