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Public Consultations

Revision of the legal framework for medical devices

[P] Recast of the Medical Devices Directives - Results of Public Consultation [/P] [P] Between 8 May and 2 July 2008 the European Commission services consulted stakeholders on the revision of the legal framework for medical devices. [/P]

 
Clinical Evaluation of Coronary Stents - Guideline

[P]The Medical Devices Clinical Evaluation Task-Force (CETF) has elaborated a guideline on the Clinical Evaluation of Coronary Stents. This guideline is intended to be annexed to MEDDEV 2.7.1 on the "Evaluation Clinical Data: a Guide for Manufacturers and Notified Bodies".[/P] [P][B]The Commission services would like to invite interested parties to submit comments before 22 April 2008[/B].[/P]

 
Public consultation on future non-energy raw materials policy

The growing global economy is putting significant pressure on the competitive situation of EU manufacturing industries and raises questions over costs and security of access to primary and secondary non-energy raw materials. The situation calls for an integrated policy which covers trade, development, environment, external relations, research and industrial policies.

 
Impacts of Good Manufacturing Practices (GMP)/ Quality System Requirements for Certain Excipients to be used in Medicinal Products for Human Use

In preparation of a Directive on GMP for certain excipients following Article 46 (f) of Directive 2001/83/EC, as amended by Directive 2004/27/EC, DG Enterprise and Industry asks excipient manufacturers and manufacturers/importers of medicinal products for human use (excipient users) to contribute to an online consultation on possible impacts of different policy options. Excipient distributors may also participate in this consultation.