Time up for EU states on breast implants directive:
This article was originally published in Clinica
Executive Summary
This week's issue of Clinica (No 1068) coincides with the August 1 deadline by which all EU member states should have transposed into their national laws the EU Breast Implants Directive in readiness for the regulations to take effect on September 1. The Directive 2003/12/EC imposes stricter manufacturing requirements on breast implants by upgrading them from class IIb (medium-to-high) risk to class III (high risk), ensuring that the notified body will have to review the manufacturer's design dossiers. Directive 2003/12/EC on the reclassification of breast implants was adopted on February 3 and published in the Official Journal of the European Union on February 4. Breast implants that are placed on the market before September 1 2003 will need to be assessed against the stricter requirements by March 1 2004.