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Full text of EU MDR (Medical Device Regulation)
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EU MDR Chapter 8 Article 108

Article 108 – Device registers and databanks

The Commission and the Member States shall take all appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics.

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