Medical Devices Directive
EDKEN Ltd and EDKEN Consulting (Ireland) Ltd are two wholly owned KCS subsidiary companies who provide the service of “Authorised Representative” to both non-UK and non-EEC based manufacturers of medical devices.
Medical Device Directive 93/42/EEC concerns those manufacturers who are based out with the EEC but wish to supply their medical device(s) for use within an EEC member state.
Where such manufacturers do not have a registered place of business in EEC and wish to place a device on the market under their own name. Such manufacturers must appoint and designate an Authorised Representative.
The role of the Authorised Representative is to register with the national competent authority as being explicitly designated by the manufacturer through a written mandate, in order that he may be addressed by authorities and bodies in the Community instead of the Device Manufacturer with regard to the latter’s obligations under Medical Device Directives 93/42/EEC.
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