European Representative Service
The European Union insists all medical device manufacturers should mark CE as a mandatory requirement.
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In Europe, medical devices sold, manufactured, imported, it is compulsory, under the Medical Devices Directive which became effective on 14th June 1998, that the Non-EEA manufacturers MUST appoint an Authorized Representative which has to be located in European Union member states to produce Technical File as and when requested by Regulatory/Notified Body.
We provide this service for long term and short term contracts with Non European manufacturers.