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Medical Device Regulation (MDR)
In Vitro Diagnostic Medical Device Regulation (IVDR)
and SAP Business One

Medical Device Regulation (MDR)
In Vitro Diagnostic Medical Device Regulation (IVDR) and SAP Business One

As a manufacturer or supplier of medical devices you will be aware of the new regulations that came in to force in May 2017. You may also know that full implementation of the regulations is required by 26th May 2020 in the case of MDR and 26th May 2022 in the case of IVDR.

Compliance with the regulations requires that you have systems and procedures in place. Your Finance and ERP software has a role to play in that preparation.

SAP Business One can help

One of the key requirements in the regulations is for all products to be labelled with a Unique Device Identifier. This information is also to be available for upload in electronic form once Eudamed is active.

This requirement is there to support the need for product traceability and, in some circumstances, product recall.

SAP Business One supports these requirements enabling full traceability of products and product batches throughout their life-cycle, from production through to sale.

If you are still using an entry level accounting system, legacy system or poorly integrated combination of systems, SAP Business One can help.

Take the next step

To find out more, call now on 0113 273 7788 or register for a software demonstration and we will contact you.


The extended version of this video includes a live demonstration of SAP Business One software. Register using the form below and we will send you a link.


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