Manage batches for medical devices

Companies that manufacture medical devices in particular are obliged to label these products with an in Batches to manage. This applies primarily to all products for implantation, In vitro diagnostics and all products manufactured from substances of animal origin. Batch management for medical devices is a legal requirement that must be strictly adhered to. The Batch number documents both the manufacturing process and the raw materials used. Under certain circumstances, batch numbers can be used to initiate product recalls.

Medical devices are products for medical use. These are intended by the manufacturer for use on humans. These include implants, injection, infusion, transfusion and dialysis products, human medical instruments, software, catheters, pacemakers, dental products, dressings, visual aids, X-ray equipment, condoms, medical instruments, laboratory diagnostics, contraceptive products and in-vitro diagnostics.

Batch characteristics

The „batch“ designation is a product feature that identifies the exact manufacturing process and is assigned by the product manufacturer. The batch number therefore allows individual products manufactured using the same production process to be identified. In the event of manufacturing-related product defects, the batch number is a crucial feature for finding affected products and, if necessary, recalling them from the market.

The batch number is often given together with the best-before date (BBD) or the expiry date. A common method for handling Articles in batches in the merchandise management is the GS1 data matrix barcode, which not only identifies the item with a GTIN, but also indicates the batch and expiry date. By scanning the barcodes all this data is captured in a single operation.

The common terms „Charge“, „Batch“, „Lot“ and "Los" can be considered synonymous. In directives such as 98/79/EC concerning in vitro diagnostic medical devices, the term "Charge" was used. In standardisation, on the other hand, the term "Lots" is more commonly encountered. In connection with semi-finished products and raw materials, the term "Bulk" is more often used.

Batch traceability

The key requirement for a functioning batch management system is traceability

The traceability (coherence) of batches makes it possible to trace the path of a faulty production batch and to retrieve the products if necessary. Batch traceability is mandatory for certain classes of products, such as medical devices or foodstuffs. After the MDR (Medical Device Regulation) traceability via batch management is mandatory for:

Medical device manufacturer
Importers of medical devices
Distributor of medical devices

A company must be able to answer the following questions:

Who carried out the quality control?
When was the quality control carried out?
Where are the batches stored?
Which production order was involved?
What quantities were taken?
What other production steps were carried out?
Where is the end product stored?
To which customer or distributor was the product delivered?

All manufacturers of medical devices are subject to stricter regulatory requirements under the MDR (Medical Device Regulation).

These are documented in the Medical Devices Ordinance, which has been in force since 26 May 2020.

The main objective of the MDR is to provide flawless medical devices to maximise patient safety. This leads to the requirement to regulate the supply chain between manufacturer and supplier.

Batch management with ERP software

Effective batch management for medical devices requires data management that fully documents all goods movements and production processes. One ERP software is therefore perfectly suited for this function:

On the one hand, the ERP system is already connected to all important business processes. For example, employees in the warehouse already record incoming goods deliveries digitally. Adding an analysable batch number therefore requires little additional effort.

On the other hand, an ERP system is not a stand-alone solution that only individual departments work with. It is a centralised information system that can be accessed by a large part of the company. This facilitates the synchronised processing of goods movements between departments and therefore the tracking of batches.

The main task of an ERP system in the context of batch tracking is to provide all information about individual batches. Once a batch number has been assigned, the ERP software centrally stores all information relating to this batch, such as the date of delivery, serial numbers, product characteristics, expiry date information, etc.
In addition, there is data that is generated during the production process, such as the position in the warehouse, the movement of goods or the processing steps carried out.

All these processes, which are managed by ERP software in batch management for medical devices, should also be validatable with reasonable effort.

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