MDR must have common language for a unified supply chain

Quality provider InfinityQS has argued that the medical device industry must develop a common language within its data systems to ensure full legal compliance and internal traceability.

Organisations within the industry such as vendors, medical device manufacturers and regulatory bodies must work together so that standardised data is captured across the industry.

The new EU Medical Device Regulation (MDR) means companies within the medical device industry must fully comply with rulings by January 2020. InfinityQS argue that whilst MDR is designed to establish a regulatory framework for medical devices, it fails to establish a unified approach to the classification and criteria of medical devices across the supply chain.

InfinityQS state: “The real challenge for an industry as large as this one, across member states and the UK, is developing a universal language that can be used for internal traceability right along the supply chain. This encompasses everything from vendors, right through to the hospitals where the end product is used.”

The company argues that a single common language would enable data acquisition and interchange across the supply chain, helping to establish how data is stored and transmitted between entities. Data analytics also enables traceability right across the supply chain to pinpoint the source of a faulty product. A common language delivers greater collaboration between the medical device industry and technology providers as the two work together, InfinityQS argues.

“With any number of organisations using different technologies and systems across any one supply chain – SAP, Infor, Microsoft Dynamics – it can be very difficult for disparate IT systems to work and communicate together. By developing a single, unified system then collaboration and traceability are much easier across the supply chain.” InfinityQS said.