Expert Advice Community

Guest

Information on product and packaging labels

  Quote
Guest
Guest user Created:   Jul 23, 2020 Last commented:   Jul 29, 2020

Information on product and packaging labels

The label information covers only UDI, but there is no information on product and packaging labels.

The product label just does not contain UDI information, UDI is one element of the packaging label. What other information is mandatory for product and packaging label for e.g. the label will have manufacturer address, date of manufacturer, symbols including serial number, etc. I am expecting a procedure for labeling which also includes what information an user manual should have for both end-users and professional users etc.

0 0

Assign topic to the user

Assign

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jul 29, 2020

Yes, I agree that product label does not contain only UDI information. However, there is no requirement both in ISO 13485:2016 and in MDR 2017/745 to have a procedure for labelling. 

Information that need to be on the label and Instruction of use are descibed in MDR 2017/745 in General safety and perfromence requirements, Annex I – in Chapter III REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE. - https://advisera.com/13485academy/general-safety-and-performance-requirements

In Article 7 Claims you can see information how clains for intended use are supposed to be stated. https://advisera.com/13485academy/mdr/claims/

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Jul 23, 2020

Jul 29, 2020