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  EU-UDI Information Available

The new regulations in the EU, MDR & IVDR, implement a system for Unique Device Identification, UDI. Initially, the regulations provided information on the UDI for labels as well as the core database elements. Subsequently, more information is available. This new information provides the details for a device manufacturer to collect the necessary information in preparation for loading it to Eudamed when it becomes available.

 

The relevant documents are:

 

MDCG 2018-1 Draft guidance on BASIC UDI-DI and changes to UDI-DI

 

MDCG 2018-2 Future EU medical device nomenclature – Description of requirements

 

MDCG 2018-3 Guidance on UDI for systems and procedure packs

 

MDCG 2018-4 Annex: UDI database – Definitions/Descriptions and formats of the UDI core elements for systems or procedure packs

 

MDCG 2018-5 UDI Assignment to Medical Device Software

 

MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation (EU) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (EU) 2017/746

 

MDCG 2018-7 Provisional considerations regarding language issues associated with the UDI database

 

UDIWG 2018-1 UDI Database, Definitions/Descriptions, and formats of the UDI core elements

 

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

 

Because the documents are not all in one place, use a Google search to find them.

 

 

 
 
 
 
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