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Rules - MDD Devices in the Distribution System after June 14, 1998The Directive makes a distinction between "placing on the market" and "putting into service" in relation to medical devices. Devices which are placed on the market by the manufacturer after June 14, 1998 must be CE-marked in accordance with the rules of the Directive.Devices which are placed on the market as "not CE-marked before June 14, 1998" may be put into service up to June 30, 2001. This special facility will give distributors and importers the opportunity to clear out their stocks of devices which have not been CE-marked for another three years as of the expiry date of the transitional arrangement. Back to index |
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