Public consultation for the proposed revision to the European Medical Devices Directive 93/42/EEC

The European Medical Devices Expert Group produced a report in 2002 on the functioning of the three EU Directives on Medical Devices:

The Report concluded that some improvement could still be made, mainly without legislation, but there was a need to modify some of the provisions in the Medical Devices Directive. The most important areas of amendment concern conformity assessment, clarification of the clinical evaluation requirements and post-market surveillance.

The Commission services, with stakeholders, prepared a draft text for amending the Medical Devices Directive 93/42/EEC. This can be found at: http://europa.eu.int/comm/enterprise/medical_devices/consult.htm

The period for consultation will remain open until 6 weeks from publication on the web site. The closing date is 25 June 2005.


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