Executive Summary

The review of the Medical Devices Directive and the Active Implantable Medical Devices Directive, the texts of which have recently been adopted by the European Council and Parliament, leave many issues unresolved, writes Amanda Maxwell. But there has been a deliberate policy to leave many matters to future deliberation to keep the texts live and relevant, as Clinica heard at the June 7-8 Management Forum meeting in London on The Revision of the Medical Device Directives. Central to the future management of the medical device Directive is the increased emphasis and powers on the procedures for make binding decisions through the Article 7 directive implementation committee.