Statement on MDR nomenclature

The GMDN was established by the European Commission on behalf of the Global Harmonisation Task Force (GHTF) in the mid-1990s to provide an up-to-date and evolving single global medical device nomenclature for the benefit of regulators and other stakeholders.

With this in mind it seems a strange decision for the EC to seek to establish its own nomenclature.

The feedback we get from regulators and others is a proliferation of nomenclatures:

• Is harmful to patients because it acts an impediment to global exchange of information about product performance and in particular patient safety concerns.

• Has the potential to add an unnecessary cost burden to manufacturers without any clear benefit.

We do welcome the EC’s recognition of the global importance of GMDN in their stated intention to ensure that “the CND nomenclature, to be mapped to the GMDN nomenclature, will be made available in the future Eudamed“.

We will work with the European Commission to better understand their needs whilst recognising that their goal of converting from GMDN to CND will be extremely difficult due to the different architecture and governance of the two systems.

The GMDN Agency will continue to invest and develop our service catalogue for the overwhelming majority of regulators and other stakeholders that are committed to realising the full utility of a truly global nomenclature.