French continue to challenge the status quo
This article was originally published in Clinica
Executive Summary
The French authorities continued to be active on the regulatory front during 1996, challenging what most other Member States of the European Economic Area accept. From discussions about the technical requirements for breast implants and condoms to negotiations on the content of the impending In Vitro Diagnostics Directive, France has been out of step with its European partners. The French authorities are even going against the spirit, if not the letter, of regulatory agreements by insisting on their right to request comprehensive information randomly about CE-marked products.