How the Medical Device Regulation presents the medtech industry with great challenges
BY JÜRGEN MÜLLER
(Published in The Produktkulturmagazin issue 1 2019)
Maintaining and managing company data in the long term is a challenging task for many companies. The IT infrastructure must be subjected to regular tests and reports must be evaluated while systems are tested for their efficiency and suitability. This alone is often enough to bring those responsible to the limits of their capacity. Yet fundamental challenges in data storage are the least of the problems when it comes to heavily-regulated industries such as the financial services sector or medical technology.
New regulations and laws require the highest level of transparency, end-to-end documentation and the absolute integrity, up-to-dateness and correctness of the core data. The Medical Device Regulation (MDR) is currently presenting thousands of medical technology companies with a major task, and many experts agree that the new regulation will heavily purge the market for a short period.
The MDR officially came into effect in May 2017 and most companies in the medical technology industry are currently undergoing a transitional period before compliance with the regulation becomes mandatory on May 26, 2020. The regulation’s objective is the complete global documentation and thus the traceability of medical products. The primary aim is to guarantee patients the highest level of protection possible; for instance, by making it easier to recall faulty products. On the other hand, the regulation protects manufacturers themselves from product piracy. The initial step involves comprehensive approval documentation for industry manufacturers and traders, an effort that is estimated to be enormous. The fact that the regulation does not offer any preservation of the status quo is precarious for companies: the provisions not only apply to newly manufactured products, but also to older ones.
The essence of the MDR for manufacturing companies is a uniform labelling system for medical products developed by the US Food and Drug Administration (FDA) – the so-called UDI (Unique Device Identification) code. The UDI code is a unique product number that is assigned to each medical product. It consists of a static and a dynamic part. The static part contains a unique code for the respective product, while the dynamic part changes in accordance with the respective product batch. This allows every product in circulation to be identified with absolute certainty. There are currently three accredited standards for the UDI code: GS1, HIBC and ISBT 128. The UDI product number is supplied to Eudamed, the European Database on Medical Devices. This database is an institution specifically set up by the European Commission and EU member states in order to gather information on all medical products within the EU. This increases the transparency in the market and improves cooperation in monitoring.
In addition to identifying the product with the help of the UDI code, the MDR also comprises additional documentation obligations. These include a description of the product and all its variants, configurations and accessories, its intended purpose, as well as the verification and validation of the product and therefore the evidence that the fundamental safety and performance specifications have been met. Furthermore, the documentation includes risk management files and detailed information on the product’s design and production.
For companies to be able to provide this level of transparency, they first need transparent information management – from the data procurement and preparation all the way to the distribution of the data. The highest level of reliability is required for the maintenance, management and deployment of product data in the product information management (PIM) system – and that applies to all languages and across the entire process chain. All-encompassing multi-language support is particularly indispensable to companies that produce in multiple European countries. This is the only way in which to consistently manage company-specific terminology. The number of users and volume data should be of no importance, a modern architecture with comprehensive scalability is the basis for efficient performance and operational reliability. Continuous and all-encompassing quality management of data and data governance strategies is especially necessary in a sensitive industry such as medical technology – so that manufacturers and traders can always rely on the product data. Analysis, reporting and visualisation functions also help companies provide continuous transparency and control in all process flows. Processes can therefore be controlled centrally, which makes them easier to audit and allows problems to be identified more rapidly. Last but not least, the system’s user-friendliness must ensure the system is accepted quickly and is used by all those involved without issue.
It is only with the help of performant product information management (PIM) and master data management (MDM) systems that medical technology companies can ensure that they will master both current and future challenges. Current developments surrounding the MDR require a reorientation in terms of data management, and companies would be well advised to look for a suitable solution as soon as possible. Not only will they then avoid business-critical dangers, they will also automatically help themselves achieve important advantages, therefore allowing companies the opportunity to review and optimise their internal processes and systems. They gain significant protection against product counterfeiting and piracy, while communication with suppliers and customers becomes more efficient thanks to optimised information management. Warehouse management can also be optimised with improved data storage. What may seem like a major challenge at first glance can lead to more efficient processes and reduced company costs in the long term. One thing is for certain: there is no way to avoid digital transformation.
After studying mechanical engineering and gaining an MBA, Jürgen Müller initially worked in international management consulting before switching to the software industry and taking over the management of Viamedici Software GmbH in 2002. Jürgen Müller is an expert in digitization and product information management.
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