Commission makes official complaint to French:
This article was originally published in Clinica
Executive Summary
The European Commission has officially complained to the French government over its intention to introduce more stringent regulatory requirements for high-risk devices. Six EU countries (see Clinica No 808, p 1) plus the European Commission have now told France its go-alone proposal for companies to notify them three months ahead of product launch would create a barrier to trade. The opposition forces France to delay introducing its new requirements until August 5.