Blog updated on 15th February 2021 by Fraser Dunlop
The importance of the medical supplies sector has been brought into sharp focus by the Covid-19 pandemic. The national effort to support the NHS with PPE and ventilation equipment has been substantial. Increased public interest in the sector has also come at a time of significant legislative change - and traceability is a key part of that legislation.
Traceability is the ability to identify, track and trace elements of a product or substance as it moves along the supply chain from raw materials to finished product and out through your distribution network to the customer. Traceability is important because it helps you improve quality control. It also provides pinpoint accuracy and flexibility to recall products quickly and issue replacements.
In the medical supplies sector traceability is mandated by law. In the UK, the Medical Device Regulations (MDR) and the In Vitro Diagnostic Medical Device Regulations (IVDR) will apply in full on 26 May 2022. In EU Member States equivalent regulations come into force a year earlier, on 26 May 2021.
Article 25 of the MDR and Article 22 of the IVDR legislation oblige distributors to achieve an appropriate level of traceability for all medical devices that they distribute.
Medical device traceability is achieved through maintaining detailed records in relation to the sourcing and supply of medical devices. In the event of a Field Safety Corrective Action (FSCA) being triggered, it will be necessary to locate other customers using devices that could also be affected by the FSCA, and in these cases rapid access to detailed and reliable records is essential. Without these records, swift, decisive and precise action is simply not possible. Compliance with the MDR and IVDR Regulations is broken and the business, its customers and end users of the devices face enormous potential risk.
If your company is looking for ways to streamline and improve traceability of goods you supply, SAP Business One offers a solution. With SAP Business One from LAKE you can:
If you would like to find out more about LAKE and SAP Business One, please register for one our regular SAP webinars or call me now on 0113 273 7788.
by Fraser Dunlop
© 2023 LAKE