Elsevier, a global leader in information analytics specialising in science and health, has announced its use of Global Medical Device Nomenclature (GMDN) data to provide important clinical and vigilance information on medical devices.
The new initiative will see data from GMDN, which is used by the FDA and other regulators worldwide for device approvals and certification, integrated into Elsevier's Embase database, providing a standardised, one-stop solution for manufacturers looking to develop new devices or monitor existing ones. By combining the taxonomies of Elsevier and GMDN, the aim is to provide clearer guidance to help organisations comply with new incoming regulations around device safety.
Historically, approvals and certifications for medical devices have been less stringent than for new drugs. However, with the new Medical Device Regulation (MDR) coming in May 2020 and the In-Vitro Diagnostic Medical Device Regulation (IVDR) in May 2022 in the European Union – as well as the expectation of similar new regimes in the United States – the environment is dynamic. The MDR will replace existing directives and put in place more rigorous requirements and additional inspections of technical documentation. Other improvements of the MDR include: a new risk classification system for in vitro diagnostic medical devices in line with international guidance; increased transparency and traceability; intensified post-market surveillance requirements for manufacturers; and improved coordination of vigilance and market surveillance between EU countries.
IVDR will place a range of new obligations on device manufacturers, including: Expanding the scope of products covered to include high-risk devices within hospitals, diagnostic (including internet based) services and genetic testing services; Further requirement from manufacturers to collect and retain post-market clinical data; and Revocation of all previous provisions, meaning that companies cannot 'grandfather' in approvals.
The scope of the regulations means that this is a global challenge: it is not just manufacturers based in Europe who are affected, but any firm that wants to distribute or market to the European market.
A potential shorter avenue is the equivalence route, where a manufacturer can demonstrate sufficient equivalence with another device that is already cleared. This means that GMDN data and vocabulary, which is already used by the FDA for approvals, is especially valuable as it can dramatically smooth the approvals process.
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