MDR and IVDR advice could be provided through GMDN data
Elsevier, a specialist in information analytics within science and health, aims to use 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 Food and Drug Administration (FDA) and other regulators worldwide for device approvals and certification, integrated into Elsevier’s Embase database. This will hopefully provide a standardised solution for manufacturers who are looking to develop new devices or monitor existing ones. Additionally, the aim is to provide clearer guidance to help organisations comply with new incoming regulations around device safety.
“With new devices being created for the hospital, the patient and the home, the market for medical devices is going to boom over the next few years,” said Mark Wasmuth, CEO of the GMDN Agency. “Experts are already predicting it’ll be worth over $430 billion by 2025, a figure that is likely to be boosted further as the line between drugs and devices is blurred thanks to innovations in implantables, injectables and ingestibles.
“To continue safeguarding patients, there is an urgent need for greater clarity and structure around how we monitor medical devices. We’re pleased Elsevier is using the GMDN to make post-market surveillance easier and more accurate.”
Previously approvals and certifications for medical devices have been less stringent than for new drugs. However, this is anticipated to change as a result of the upcoming Medical Device Regulation (MDR) in May 2020 and the In-Vitro Diagnostic Medical Device Regulation (IVDR) in May 2022, within the European Union.
The MDR will replace existing directives and put in place more stringent requirements and additional inspections of technical documentation including:
- 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.
- Improved coordination of vigilance and market surveillance between EU countries.
IVDR will also 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.
- Revocation of all previous provisions, meaning that companies cannot ‘grandfather’ in approvals.
Any firm that wants to distribute or market to the European market will be affected by these new regulations.
GMDN data could be particularly valuable when a manufacturer demonstrates sufficient equivalence with another device that is already cleared – a process which is already used for FDA approvals.
“These new regulations place a lot more responsibility on manufacturers for post-market monitoring and clinical evidence obligations,” said Cameron Ross, managing director of Life Science Solutions, Elsevier. “Many organisations are confused about how to go about meeting these obligations and, unless there is a standardised taxonomical approach, the result will be delays in the approvals process or even products having to be shelved entirely.
“Mapping our history and institutional knowledge of search and taxonomy to the GMDN database will enable users to quickly and easily find the information they need to prepare documentation for regulators – ultimately getting new and better devices to market so they can benefit patients.”