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MDRQ #2182

MDRQ #1673: ANNEXES

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

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:

Added by Anonymous almost 3 years ago. Updated 7 months ago.

Status:
Released
Priority:
Low

Description

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:


Subdefinitions

MDRQ #2183: a) name or trade nameReleased
MDRQ #2184: (b) device version or model,Released
MDRQ #2185: (c) labelled as single use,Released
MDRQ #2186: (e) need for sterilization before use,Released
MDRQ #2187: (f) quantity of devices provided in a package,Released
MDRQ #2188: (g) critical warnings or contra-indications: e.g. containing latex or DEHP.Released

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