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Rules - MDD Existing Devices at HospitalsThe Directive does not require that devices already purchased and installed at hospitals must be CE-marked.Similarly, the rules on CE marking do not apply to devices that are manufactured by the hospitals and remain there. If, however, the devices are transferred in return for payment or made available to another natural or legal person free of charge, it is considered marketing and the rules referred to above will be applicable. The requirement for market feedback does, however, apply to all devices at hospitals. Persons responsible for the operation of public and private hospitals are under an obligation to notify the Danish Medicines Agency of any serious incidents involving medical devices without delay. Back to index |
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