Module 16 2024
17/10/2024
Basic UDI
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
19
Traceability
• The definition of ‘Traceability’ with the GS1 Global Traceability Standard for Healthcare is: • Traceability is the ability to track forward the movement through specified stage(s) of the extended supply chain and trace backward the history, application or location of that which is under consideration
• Therefore Track + Trace = Traceability
• This subject is of high importance and is increasing globally
The Organisation for Professionals in Regulatory Affairs
20
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