E.U. postpones medical device directives recast
This article was originally published in The Gray Sheet
Executive Summary
European Commission will not draft a recast of the Medical Devices Directives this year, as was originally planned, in order to take more time to prepare, according to a spokesman for EC Commissioner for Enterprise and Industry Gunter Verheugen. Many of the roughly 200 stakeholders who responded to a May 2008 EC questionnaire about the recast, which calls for more aggressive, centralized oversight of device regulation in Europe, had said the recast was premature, though most agree "certain elements could do with revision," according to Elisabethann Wright, a life sciences attorney at Hogan & Hartson's European bureau (1"The Gray Sheet" July 14, 2008, p. 5). A revised timeframe for the recast has not yet been set