Lot number coding
Our company recently purchased Advisera’s package of ISO 13485 templates for implementation in our company as we are starting producing class I medical devices (surgical gowns) to supply the Portuguese market as soon as possible.
I’m aware you provide a meeting to discuss doubts about the templates provided, but at the moment I’m in a hurry to solve an issue regarding the lot number coding and I didn’t find any information about that in the package purchased.
Is there any template to help us code the lot/batch number of a medical device or mandatory information that we should include in that code? We want to allocate that code automatically, but we don’t know what requirements to demand from the automatic batch number allocation.
Would you kindly help me with this matter?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
No, there is no template for coding lot/batch number since it is very specific for each company and the medical device itself. We have section 3.3.7 Identification and traceability in the 11_Procedure_for_Production_and_Service_Provision where we describe what has to be done and what responsibilities there are.
There is no regulations for medical devices which elements LOT number must have, so you can define it in any way that you find the most appropriate. Usually, it contains information about the location where the product is manufactured (in case when the company has several locations), date of the production, year of the production; sometimes it can have a production line on it and so on.
However, be careful that from May 2021. You will need a UDI number. Which elements are necessary to be part of UDI number you can find in the following articles from Medical device regulative 2017/745:
- EU MDR Article 27 – Unique Device Identification system - https://advisera.com/13485academy/mdr/unique-device-identification-system/
- EU MDR Annex 6 – Information to be submitted upon the registration of devices and economic operators in accordance with Articles 29(4) and 31; core data elements to be provided to the UDI database together with the UDI-DI in accordance with Articles 28 and 29; and the UDI system - https://advisera.com/13485academy/mdr/information-to-be-submitted-upon-the-registration-of-devices-and-economic-operators-in-accordance-with-articles-294-and-31-core-data-elements-to-be-provided-to-the-udi-database-together-with-the-ud/
For more information please see the following article:
- How to comply with the MDR requirements for medical device labels - https://advisera.com/13485academy/blog/2020/09/20/how-to-create-medical-device-labels-compliant-with-mdr/
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Sep 30, 2020