Since 1991 Medical Device experts from around the world (regulators, healthcare providers and manufacturers) have worked together to create the Global Medical Device Nomenclature (GMDN). This work was requested by the inter-governmental body, the Global Harmonisation Task Force (GHTF) to help accelerate international medical device regulatory harmonization and convergence. The GHTF has now been superseded by the IMDRF (see www.imdrf.org).
The GMDN Agency is the non-profit organisation that is responsible for the ongoing maintenance of the GMDN. It is a registered UK charity, subject to an independent audit each year and regulated by the UK Charites Commission. Our Annual Report is available from the Charities Commission website.
The Agency’s objects are:
To preserve and protect health and to relieve sickness for the public benefit by developing and maintaining the “Global Medical Device Nomenclature”, a system of internationally agreed descriptors used to identify medical device products which will meet a global need for identification purposes.
The GMDN Agency has a Board of Trustees.
John Wilkinson, OBE, is Director of Devices at the MHRA which he joined in 2012 and he served as Chair of the Executive Group of the European Competent Authority Network between 2014 and 2018. Prior to joining the MHRA, John was Chief Executive of Eucomed, the European medical technology industry association.
His earlier experience included the role of Director General of the Association of British Healthcare Industries and a number of roles in the medical devices industry, both in the UK and the USA, with Becton Dickinson and the BOC Group. These were followed by a period as Chief Executive of an early stage medical imaging company.
John holds a first degree in Zoology from the University of Aberdeen and an MBA from the University of Warwick.
He was awarded an OBE for services to the medical devices industry in the 2010 New Year’s honours list.
Dr Elizabeth D. Krell is retired from a career at the US FDA’s Center for Devices and Radiological Health (CDRH) where she served as the CDRH Deputy Director for Science, as well as Acting Senior Science Advisor to the FDA Commissioner, and Director of FDA’s Office of Science Coordination and Communication. She is a past Director of CDRH’s Office of Science and Technology, predecessor to the Office of Science and Engineering Laboratories, and past Chair of the Global Harmonization Task Force.
Dr. Krell served as Executive Vice President for Technology and Regulatory Affairs for AdvaMed and is a current or past member of a number of medical device-related boards as well as those for non-profit community organizations.
Dr. Christina Tong is currently with the National University of Singapore advising Professors and Researchers in Translational Activities from Research to Commercialisation. She previously held positions as Group Director at the Health Sciences Authority of Singapore responsible for the Group’s Regulatory Activities in Drugs, Medical Devices, and other Health Care Products; as well as Senior Vice President in Vertex Management, a venture capital management company in the Singapore Technologies Group. She was also on the Board of a number of technology and biotech start-ups in US, Europe and Asia.
Janet E. Trunzo is Senior Advisor to the President and Senior Executive Vice President, Technology and Regulatory Affairs, for the Advanced Medical Technology Association (AdvaMed) and leads a team of regulatory experts.
During her tenure at AdvaMed, she has focused on the passage of the Medical Device User Fee and Modernization Act of 2002 and subsequent updates. She also concentrates on global regulatory harmonisation and representing the U.S. device industry on the Global Harmonization Task Force. She also chairs the Regulatory Committee for the Global Medical Technology Alliance.
Previously Janet held positions at Hybritech, Inc., a medical device and diagnostics manufacturer, and Scripps Clinic and Research Foundation, a hospital, diagnostic clinic and research institute.
Mark joined the GMDN Agency at the start of 2010 and is now the CEO. He is a Chartered Engineer and Member of the IET. Mark has an MSc in Engineering from Cranfield University.
During this time the Agency has increased membership from 400 to over 5,000 manufacturers and regulators in over 120 countries. Mark has been to every continent promoting the adoption and use of the GMDN to support regulation as the single harmonised system for device naming and grouping of medical devices.
Mark previously worked as the International Projects manager at the British Standards Institution and as a Senior Engineer at Instron Ltd.
The Policy Advisory Group provides advice to the Board of Trustees on matters of relevance to the satisfactory maintenance of the GMDN, including:
For more information about the PAG, please contact us in writing.
Independence and trust are important values for the GMDN Agency. We work with medical device regulators, manufacturers, healthcare providers and their representative bodies to ensure we understand and respond to their needs and to promote international harmonisation of medical device standards and regulation.
The GMDN Agency is a member of the following organisations or we have signed a Memorandum of Understanding or licence or similar document.
In addition, the GMDN has been licenced for use to the government of the following countries: