As originally asked by Suresh Kumar Muniandy.

Dear members,
I have a question on the MDR labelling requirements -UDI. Is there any exemption on placing serialization numbers on UDI labels if your product is manufactured in bulk and is at class IIb (non invasive)?
Appreciate any comments on this. Thank you.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Gary Saner will know the answer.

Gary Saner
Sr Mgr, Information Solutions-Life Sciences at Reed Tech
AS APPROPRIATE, the EU MDR device label must include the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol. As to UDI, in general, if the Lot and/or Serial Number appear on the product label, then they are required to be coded in the Production Identifier (PI) portion of the UDI and be included in the UDI carrier on the device and packaging labels.
I am not aware of any serialization label exemptions for bulk production of your Class IIb device. However, the EU MDR does allow for some special conditions that I collected below for you to review.
• Limited Label Space for UDI: only AIDC format is required (If home care, only HRI format is required)
• Limited Package Space for UDI: the UDI carrier may be placed on the next higher packaging level
• Impractical Product Label: label information may appear on the unit packaging or on the packaging of multiple devices
List continued in Part 2 of this response
Gary Saner gsaner@reedtech.com

Gary Saner
Sr Mgr, Information Solutions-Life Sciences at Reed Tech
Part 2 of 2 – continued from above message…
• Single-use Devices of Classes I and IIa Packaged and Labelled Individually: “the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.”
• Devices Exclusively Intended for Retail Point of Sale: “the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.”
• Shipping containers are exempted from the UDI carrier requirement
If desired, you may also contact me directly for more info.
Gary Saner gsaner@reedtech.com

🔵Suresh Kumar Muniandy🔴
Chief Quality Officer at Oro Clean Chemie AG
Thanks Gary.

Mahzad Pakzad
Urgently need employment! Electro-Mechanical Engineer, DFM, NPI, Device D&D, Automation Engineer, Lean, Process Eng,
?! Product or component of a product? Is this final product going to be used by consumer as is? Labeling is generally practiced to prevent misuse of a product, I am wondering what the product is, where is it used! Risk assessment is required, try common sense to evaluate risks of not labeling your product “not counting on tribal knowledge” of what it is and how to use it!

Mahzad Pakzad
Urgently need employment! Electro-Mechanical Engineer, DFM, NPI, Device D&D, Automation Engineer, Lean, Process Eng,
https://youtu.be/8ijmsCRYKrU

Marc Saab
Digital Health – Medical Device – Consumer Wearables
Arno Pantalone, MS RA

🔵Suresh Kumar Muniandy🔴
Chief Quality Officer at Oro Clean Chemie AG
On the product. It’s for disinfectants used in the dental industry. It won’t be used inpatients but rather on the instruments being used.