Module 16 2022
05/09/2022
Unique Device Identification (UDI) – What is it? Basic UDI-DI • Virtual (not printed on packaging) • Included in EUDAMED, Certificate, Declaration of Conformity
Product Family Eg Latex Gloves
UDI-DI & PI •
Printed on single pack and tertiary packaging levels
Product Eg Latex Surgical Glove size 6.5
Product Eg Latex Surgical Glove size 7.0
Product Eg Latex Sensitive Glove size 6.5
Product Eg Latex Micro Glove size 6.5
Included in EUDAMED
•
Product Eg Box of 25 pairs of gloves
Product Eg Box of 25 pairs of gloves
Product Eg Box of 25 pairs of gloves
Product Eg Box of 25 pairs of gloves
Product Eg Shipper Box of 4 inners or 200 pairs of gloves
Product Eg Shipper Box of 4 inners or 200 pairs of gloves
Product Eg Shipper Box of 4 inners or 200 pairs of gloves
Product Eg Shipper Box of 4 inners or 200 pairs of gloves
The Organisation for Professionals in Regulatory Affairs
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EUDAMED & Databases
• In Healthcare there are two different types of datapool: • Supply Chain Stakeholders such as distributors, wholesalers and Healthcare Institutions – such as hospitals, pharmacies, clinics etc. This is a practical requirement which not only gives traceability of product through to a specific patient but also helps to improve internal systems such as stock control, stock location, cost per episode, etc • This works very much in the same way as the retail sector. The manufacturer uploads predetermined data to the Global Data Synchronisation Network (GDSN) and the customers download it from there. This will be information required within the supply chain and although it may contain elements of those listed before there will be a lot more practical information such as weights and dimensions.
The Organisation for Professionals in Regulatory Affairs
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