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