Informazione tecnica HSE / 25 ° anno
/ Documenti disponibili:
44.311
/ Documenti scaricati: 31.940.877
/ Documenti scaricati: 31.940.877
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
____________
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Draft guidance on basic UDI-DI and changes to UDI-DI |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:
Il Documento illustra, con un esempio pratico, il “metodo di procedere” alla VR Direttiva macchine in accordo con l'Appendice...
Regolamento (UE) N. 547/2012 DELLA COMMISSIONE del 25 giugno 2012 recante modalità di applicazione della direttiva 2009/125/CE del Parlamento europeo e del Consiglio in mer...
Report 51 del 23/12/2022 N. 04 A11/00144/22 Finlandia
Approfondimento tecnico: Spaccalegna a cuneo
Il prodotto, di marca Timco, mod. 7 T, 51 cm, ...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024