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Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
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5.General principles of the UDI database
5.1.The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex.
5.2.Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database.
5.3.Appropriate methods/procedures for validation of the data provided shall be implemented.
5.4.Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.
5.5.The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.
5.6.The database shall allow for the linking of all the packaging levels of the device.
5.7.The data for new UDI-DIs shall be available at the time the device is placed on the market.
5.8.Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.
5.9.Internationally accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.
5.10.The user interface of the UDI database shall be available in all official languages of the Union. The use of free-text fields shall, however, be minimised in order to reduce translations.
5.11.Data relating to devices that are no longer available on the market shall be retained in the UDI database.
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