EMDT_European Medical Device Technology

European Medical Device Technology, Summer 2015

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14 | Summer 2015 European Medical Device Technology emdt.co.uk regulatory The new UDI regulation also modified parts of 21 CFR Part 803, the Medical Device Reporting regulations, including: 0 Sec. 803.3: addition of definitions related to UDI 0 Sec. 803.32: the need for a user facility to include the UDI in an adverse event report 0 Sec. 803.33: the need for a user facility to include the UDI in an annual report 0 Sec. 803.42: the need for an importer to include the UDI in an adverse event report 0 Sec. 803.52: the need for a manufacturer to include the UDI in an adverse event report Regulations in 21 CFR Part 806, Cor- rections and Removals, have also been impacted by the new UDI regulations, including: 0 Sec. 806.2: new definitions related to UDI have been added 0 Sec. 806.10: the need to include the UDI or the universal product code (UPC) that appears on the device label or on the device package in the correction or removal report 0 Sec. 806.20: the need to record the UDI or UPC when corrections or removals are not required to be reported to FDA In addition, several provisions of the U.S. quality system regulation in 21 CFR Part 820 have been modified as a result of the new UDI regulations, including: 0 Sec. 820.3: addition of definitions related to UDI 0 Sec. 820.120: the need to include an inspection of the correct UDI or UPC during labeling inspection before the release of storage of labeling 0 Sec. 820.184: the need to include in the device history record (DHR) or refer to the location of the UDI or UPC 0 Sec. 820.198: the need to include the device UDI or UPC in the complaint investigation record 0 Sec. 820.200: the need to include the UDI or UPC in service reports Similar changes as those listed above were made to the FDA medical device recall authority regulations in 21 CFR Part 810, the premarket approval regulations, device tracking regulations in 21 CFR Part 821, and to postmarket surveillance require- ments in 21 CFR Part 822. International and European Activity In 2008, the Global Harmonization Task Force (GHTF) established an ad hoc working group, chaired by the European Commission, on the development of an internationally coordinated approach to UDI. In September 2011, the GHTF adopted the guidance document, "Unique Device Identification (UDI) System for Medical Devices" to provide a means of harmonizing international UDI require- ments. The GHTF has since been replaced by the International Medical Device

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