The GMDN was compiled based on international standards in the early 1990’s. The work was mandated by the European Commission to support the implementation of the first European Medical Device Safety Directives. Initially, the GMDN dataset was published as ISO 15225 in 1997 and since that time the use of the GMDN has spread throughout the world. Today, the GMDN Agency provides a membership service via a website and operates out of offices in Oxford, UK.
In May of this year, Health Canada announced its adoption of the GMDN system;|
“Health Canada’s decision to use the GMDN is in line with the recommendation of the International Medical Device Regulators Forum (IMDRF) and supports the Federal Government’s Open Government initiative by improving the quality of medical devices data available to the public and leading to greater transparency.” The article indicates that review of codes submitted by manufacturers will be reviewed for accuracy prior to adding to the database. If, for any reason, a company does change their products associated GMDN code, they will have to be sure to update the FDA GDUID as well to harmonize.
All new product license applications and renewals will require GMDN codes where they will be reviewed for accuracy and Health Canada indicates this will not delay the processing of applications and a screening deficiency will not be issued.
Canada is already a member of the MDSAP program and requires such certification for product license and now it adds GMDN codes. These steps contribute to a global, transparent, and streamlined approach to medical device regulation in Canada.
In March 2018, FDA published GUDID Enhancements, that include recording device premarket submission numbers and making this information public (except for manufacturer-designated confidential elements). The purpose for this enhancement is to “provide an essential link to information about device safety and effectiveness; making public as part of the GUDID DI record information is crucial to achieving the public health benefits of UDI.”
As we all prepare for the EU Medical Device Regulation (MDR) and in vitro Diagnostic Regulation (IVDR) UDI system to be launched (mid-2020 or later), we can only hope that EU will be capitalizing on the programs existing already in Canada and the US. For UDI we see that although there is overlap, EU also introduces additional requirements due to its broader use of UDI in market surveillance activities where it plays a central role in the transparency database EUDAMED. As for GMDN, the road is still fully open. And as EU already brings a lot of changes, sticking to GMDN for nomenclature might bring some of the expected IMDRF harmonization.
Lorry & Gert