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We import a range of own-label medical devices from China. These are legitimately CE marked by the the factory and comply with the MDD Directive. We ensure that we are supplied with all Declaration's of Conformity along with the technical files and any other relevant documentation that is available. We make no changes to the products whatsoever apart from have the factory print our logo onto the top and print our own box when necessary.
Whilst by law we become the 'manufacturer', we have been informed that we don't actually need to compile our own technical files or declaration of conformity since these would be identical to that of the OEM. We have been advised however to draw up a basic contract between ourselves and all our factories stating that they agree to keep us informed of any product changes / changes to the declaration and to confirm that all documentation is legitimate.
I assume this is a widely-used contract and hoped there was a basic template available, or if not could you be so kind as to advise of some of the points it must contain, as I plan on compiling it myself.
Whilst by law we become the 'manufacturer', we have been informed that we don't actually need to compile our own technical files or declaration of conformity since these would be identical to that of the OEM. We have been advised however to draw up a basic contract between ourselves and all our factories stating that they agree to keep us informed of any product changes / changes to the declaration and to confirm that all documentation is legitimate.
I assume this is a widely-used contract and hoped there was a basic template available, or if not could you be so kind as to advise of some of the points it must contain, as I plan on compiling it myself.
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