MDRQ #2188
MDRQ #2073: ANNEX VI INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM
MDRQ #2122: PART C: THE UDI SYSTEM
MDRQ #2169: 3. The UDI
MDRQ #2182: 3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:
(g) critical warnings or contra-indications: e.g. containing latex or DEHP.
Status:
Released
Priority:
Low
Description
(g) critical warnings or contra-indications: e.g. containing latex or DEHP.