Medical Device Regulation must dispense with jargon for a unified supply chain
Published: 28 June 2017 - Sarah Mead
Manufacturers and vendors within the medical device industry must establish a ‘common language’ to allow information to become integrated and aggregated throughout the supply chain.
The medical device industry must develop a ‘common language’ within its data systems to ensure full legal compliance and internal traceability. Vendors, medical device manufactures and regulatory bodies must work together to ensure standardised data is captured across the industry. This is according to quality management provider, InfinityQS.
The recent passing of the EU Medical Device Regulation (MDR) on 5th May 2017 means any organisation associated with the medical device industry must fully comply with rulings by January 2020. Designed to establish a ‘…regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation,’ the MDR fails however to establish a unified approach to the classification and criteria of medical devices across the supply chain.
“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,” says InfinityQS.
A single common language enables data acquisition and interchange along the supply chain to establish how data is stored and transmitted between entities. In support of this, data analytics 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.
“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 concludes.