I am currently helping a medical device manufacturing to get ISO 13485 certification and we are now currently in the Identification and traceability stage - how to create LOT number? I would like to get more information on that.
A lot number is an identification number assigned to a particular quantity or lot of material from a single manufacturer. Lot numbers can typically be found on the outside of packaging. The lot number enables tracing of the constituent parts or ingredients as well as labor and equipment records involved in the manufacturing of a product.
This enables manufacturers and other entities to perform quality control checks, calculate expiration dates, and issue corrections or recall information to subsets of their production output. It also gives consumers an identifier that they can use in contacting the manufacturer and researching the production of goods received. For example to trace back the origin of medical device, in case of a public health problem.
Neither FDA or European regulations for medical dev ices define requirements for LOT number, 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), person who authorized the release of product, information about the raw materials being used in manufacturing of the particular product.
It primarily depends on the type of raw material. It is the manufacturer who determines what the raw material must be, what its specifications are. Sometimes these specifications are generally defined (eg chemical composition), and sometimes the manufacturer defines which specifications and which performance raw material must have (for example length, strength, density, elongation, etc.). When receiving raw material, an input check is performed to see if the raw material matches everything that is requested. It can be just a review of the documentation, it can be a visual inspection of the goods that have arrived, but also some kind of laboratory analysis.
I have another question. is any genaral rules that provide me to define batch/LOT number in only one way. For expample I have one product but diffrent sizes for example CVC catheter 8F size and the second one CVC catheter 9F size. What are the rules ? I have to create two seperate lots even its the same line production or it is my decision how to create that ? For example is it possible to settle one LOT number for diffrent products if I am able to show proper trackability.
Basically, you can settle the LOT number however you want if you can prove the traceability. It is up to you. However, if you are on the EU market, the Lot number is partially defined with UDI and there are rules on how UDI-PI must be constructed.
For the implants, yes it is necessary that the lot number must be on the device except the device is not too small. For all implants, there should be an implant card. According to the MDR 2017/745, Article 18. implant card must have the following information:
information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address, and the website of the manufacturer
any warnings, precautions, or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations, or environmental conditions
any information about the expected lifetime of the device and any necessary follow-up
any other information to ensure the safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.