Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. The work was mandated by the European Commission in order to provide the necessary tool to carry out the implementation of the Medical Devices Directive, including the European databank for medical devices (Eudamed). The GMDN is currently used by Members States in the National Competent Authority Reports as part of the outgoing EUDAMED system to exchange information on device URL European Directives on on medical devices Directive 84/539/EEC and Directive 90/385/EEC will be repealed on 26 May 2021. The GMDN was not specified for the UDI database system proposed in new European Regulations URL intended to be used by manufacturers of medical devices who have their own UDIs (unique device identifiers) and traceability. Governance The GMDN meets the need to identify medical devices at the global level, as identified in the Global Harmonization Task Force (GHTF) that have since disbanded (2012) and replaced by the URL The GMDN Agency has recently finalised the business principles that will form the basis of a   long term cooperation with the IHTSDO. The Cooperation Agreement shall result in the use of the GMDN as the medical device component of SNOMED CT. This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The following objectives were agreed: See also Unique Device Identification European databank for medical devices IHTSDO - International Health Terminology Standards Development Organisation Meddra - Terminology for the pharmaceutical industry. Medical device
Medical device experts from around the world (manufacturers, healthcare authorities and regulators) compiled the GMDN, based on the international standard ISO 15225. Governance The GMDN meets the need to identify medical devices at the global level, as identified in the Global Harmonization Task Force (GHTF) that have since disbanded (2012) and replaced by the URL The GMDN is required by the UK's national medical device regulator, the Medicines and Healthcare products Regulatory Agency The government agency responsible for medical device safety in Australia Therapeutic Goods Administration require the GMDN when registering a product within its ARTG system The GMDN Agency has established long term cooperation with the IHTSDO. The Cooperation Agreement shall result in the use of the GMDN as the medical device component of SNOMED CT. This Agreement is consistent with the aims of both organisations to minimise duplication and to support harmonisation. The following objectives were agreed: See also Unique Device Identification IHTSDO - International Health Terminology Standards Development Organisation Meddra - Terminology for the pharmaceutical industry. Medical device
D
The work was mandated by the European Commission in order to provide the necessary tool to carry out the implementation of the Medical Devices Directive, including the European databank for medical devices (Eudamed).
D
The GMDN is currently used by Members States in the National Competent Authority Reports as part of the outgoing EUDAMED system to exchange information on device URL European Directives on on medical devices Directive 84/539/EEC and Directive 90/385/EEC will be repealed on 26 May 2021. The GMDN was not specified for the UDI database system proposed in new European Regulations URL intended to be used by manufacturers of medical devices who have their own UDIs (unique device identifiers) and traceability.
R
Agency has recently finalised the business principles that will form the basis of a
is required by the UK's national medical device regulator, the Medicines and Healthcare products Regulatory Agency
A
The government agency responsible for medical device safety in Australia Therapeutic Goods Administration require the GMDN when registering a product within its ARTG system
A
The GMDN Agency has established
D
European databank for medical devices