End of year roundup at GMDN


2019 was an exceptionally busy year for us at the GMDN Agency. The start could have been better, with the European Commission announcing the decision to not use the GMDN as a requirement for the MDR/IVDR. We will continue to work closely with the EC to help manufactures provide accurate device submissions to the new EUDAMED III, when it is available. Meanwhile the other IMDRF members continue to implement and use the GMDN. In March, with the support of the Russian Federation, we signed a cooperation agreement with the Eurasian Economic Commission, implementing the use of the GMDN as part of their regional data exchange agreement. We welcomed our new Chair of Trustees John Wilkinson in April and he has been busy visiting IMDRF members to discuss their ongoing needs. This also coincided with our new FREE Basic membership offering, that has been requested by several stakeholders including the EC and the WHO. This has proved incredibly popular with over 5,000 new members to date and several governments that have decided now is the time to join our international community of users. It has meant that the team have been very busy with your term enquiries, so I apologise for any delay in our service you may have experienced. The US FDA are using the GMDN more actively as the GUDID becomes a valuable global resource and it was very pleasing to see the positive conclusions of two reports from AHRMM’s Learning UDI Community about the value of using GMDN with UDI records. At the end of the year we were very honoured to be invited to join the Asian Harmonization Working Party (AHWP) and we look forward to working with their members.

This year we expect to see the launch of several practical applications by our customers that use the GMDN for more accurate device identification and grouping, which we hope will provide better decision support in the healthcare sector.

Thank you for your continued support and our very best wishes for 2020.
Mark Wasmuth, CEO