Draft guidance on basic UDI-DI and changes to UDI-DI
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Draft guidance on basic UDI-DI and changes to UDI-DI
Commissione Europea, Marzo 2018
The new Medical Device Regulations 745/2017 and 746/2017 introduce a Unique Device Identification (UDI) system for medical devices.
Main provisions related to the establishment of the UDI system are contained in Chapter III and Annex VI of the two medical device Regulations.
The main features of the UDI system and relevant obligations for operators will be provided in a dedicated Q/A paper to be published by the Commission in spring 2018.
This guidance is intended to provide a clarification on the notion of Basic UDI-DI, its use in relevant documentation and the factors triggering UDI-DI changes.
The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with same intended purpose, risk class and essential design and manufacturing characteristics.
It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item. Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner.
A UDI-DI shall be associated with one and only one Basic UDI-DI.
The architecture of the UDI database - Basic UDI-DI and UDI-DI attributes for Medical devices and In-vitro diagnostic medical devices
Figura: UDIWG 2018-2
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MDCG endorsed documents
Reference |
Title |
Publication date |
MDCG 2018-1 |
Draft guidance on basic UDI-DI and changes to UDI-DI |
March 2018 |
MDCG 2018-2 |
Future EU medical device nomenclature – Description of requirements |
March 2018 |
Other documents
Reference |
Title |
Publication date |
UDIWG 2018-1 |
UDI database. Definitions, descriptions and formats of the UDI core elements |
March 2018 |
UDIWG 2018-2 |
The architecture of the UDI database - Basic UDI-DI and UDI-DI attributes for medical devices and in-vitro diagnostic medical devices |
March 2018 |
Fonte: Commissione Europea
Collegati:
Regolamento (UE) 2017/745
Dichiarazione di conformità UE Regolamento (UE) 2017/745
Descrizione | Livello | Dimensione | Downloads | |
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udiwg 2018 2 architecture udidb.pdf |
234 kB | 14 | ||
udiwg 2018 1 guidance core elements.pdf |
278 kB | 14 | ||
mdcg 2018 2 nomenclature.pdf |
222 kB | 13 | ||
mdcg 2018 1 draft guidance on basic udi.pdf |
152 kB | 13 |
Tags: Marcatura CE Abbonati Marcatura CE Regolamento Dispositivi Medici Regolamento DMD Vitro