Any organisation in the medical device industry will be increasingly dependent on sophisticated information management systems to carry out its’ activities.
Most organisations will have databases which contain the core information needed to run internal processes. Progressive organisations will have a master data strategy to help them maintain ‘one version of the truth’ for critical elements of information. The GMDN can, and should, serve as one
those critical elements.
The role of the GMDN Agency is to ensure descriptions of products are kept up-to-date and relevant so all organisations that need to interact with each other across the globe can use the ‘same version of the truth’.
The GMDN allows companies to avoid having to maintain their own set of definitions, saving both money and valuable time, as well as ensuring a better outcome for the industry and patients alike.
Medical device markets are global, and regulators interact in many complex ways. Large regulatory bodies such as the US FDA and European Union’s CE marking system provide the foundations for other systems to ‘pick and mix’ their own regulatory requirements according to size and local
priorities.
The global harmonisation of large elements of regulation has already been achieved through the Global Harmonisation Task Force, who helped to establish the GMDN, and more recently, by the International Medical Device Regulators Forum and the Global Harmonisation Working Party. The
world’s regulatory systems work in collaboration and endeavour to be mutually supportive.
Many regulators require some form of product registration which allows authorities to critically identify and group products in ways that help organise the management of use in that country. The use of a single recognised nomenclature allows all organisations to download the same, but ever
evolving, ‘version of the truth’.
“I would argue that it is everyone’s benefit to use the same source of product identification, and this should be a core element of most medical device organisations’ master data strategy” said John Wilkinson, Chair of the Board of Trustees.
Find out more about the growing benefits of one medical device
nomenclature: https://www.gmdnagency.org/news/article/2001216
