Draft guidance on basic UDI-DI and changes to UDI-DI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Draft guidance on basic UDI-DI and changes to UDI-DI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 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, a new UDI-DI shall be required in the case of any change of the following elements: name or trade name, device version or model, labelled as single use, packaged sterile, need for sterilization before use, quantity of devices provided in a package, critical warnings or contra-indications (e.g. containing latex or DEHP), CMR/Endocrine disruptors, colour, language.
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Draft guidance on basic UDI-DI and changes to UDI-DI |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) 2017/746
Regolamento (UE) 2017/745
Dichiarazione di conformità UE Regolamento (UE) 2017/745
Regolamento (UE) 2017/745
Dichiarazione di conformità UE Regolamento (UE) 2017/745
Tags: Marcatura CE Abbonati Marcatura CE Regolamento Dispositivi Medici Regolamento DMD Vitro
