Manage Batches for Medical Devices
15 Nov

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 made 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. They 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 can therefore be used to identify individual products that were manufactured using the same production process. In the case of manufacturing-related product defects, the batch number is a crucial feature for finding the affected products and, if necessary, recalling them from the market.

The batch number is often indicated together with the best-before date (BBD) or the expiry date. A common method of 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 additionally indicates the batch and expiry date. By scanning the barcodes all this data is captured in a single operation.

The common terms batch, lot and lot can be considered synonymous. In directives such as 98/79/EC on in vitro diagnostic medical devices, the term "batch" is used. In standardisation, on the other hand, the term "lots" is more commonly encountered. In connection with unfinished products and raw materials, the term "bulk" is more commonly used.

Batch traceability

The essential requirement for a functioning batch management is traceability

Batch traceability (coherence )makes it possible to trace the pathways of a defective production batch and retrieve the products if necessary. Batch traceability is mandatory for certain classes of products, such as medical devices or foodstuffs. According to 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 for the highest possible 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 seamlessly documents all goods movements and production processes. A ERP software is therefore perfectly suited for this function:

On the one hand, the ERP system is connected to all important business processes anyway. Employees in the warehouse, for example, already digitally record incoming goods deliveries. Adding an evaluable batch number therefore causes 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 central information system that a large part of the company can access. This facilitates the synchronous processing of goods movements between departments and thus the tracking of batches.

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

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

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