What is the GMDN?

Answer

The Global Medical Device Nomenclature (GMDN) is a system of internationally agreed descriptors used to identify medical device products. The GMDN Database lists all the terms, which are currently available to name and describe medical devices, although new terms are regularly issued to cope with new medical devices innovations. The GMDN is managed by the GMDN Agency.

How can I get a GMDN Code for my product?

Answer

Only GMDN Membership can give you access to the GMDN Codes. The GMDN Agency is a non-profit organisation and the fees for membership are reviewed each year by our Board of Trustee to minimise the costs to Users. After joining the GMDN Terms and Codes are found on our website using a simple search tool. Please go to the Membership menu on the website for more information.

Do I register my product with the GMDN Agency?

Answer

No, the GMDN Agency is not a Medical Device Regulator. We make available the generic nomenclature to improve the consistency of naming medical devices. This improves communication within the heath-sector and helps Regulators better understand information concerning medical device safety.

Do all manufacturers need to find GMDN Codes for their products?

Answer

Medical Device Regulators may specify the use of the GMDN to their specific country or region. For example, regulators in the European Economic Area (EEA), request the use of GMDN to support the Conformity Assessment process required for CE marking. The Regulators in other countries are beginning to require the use of the GMDN Code in their medical device registration process.

What is the difference between a GMDN Term and a GMDN Code?

Answer

The GMDN Preferred Term is made up of several data elements, including a 5 digit GMDN Code, a Term Name and a Definition. The GMDN Database allows the user to search all the Term Names and Definitions for the most appropriate terms. Once selected, the GMDN Code is made available to the User and this is used for regulatory or data exchange purposes.

How often are new GMDN terms issued?

Answer

New terms are issued frequently following requests from Users or due to Competent Authority interaction or internal terminology enhancement requirements. The GMDN Database is updated daily.

What if my GMDN term is modified by the GMDN Agency?

Answer

If a GMDN Term Name or Definition needs to be modified to reduce its scope, it will be made 'obsolete'. Registered Members with these particular GMDN Codes listed in their 'My Terms' menu will be notified automatically by email, so that Users can consider whether or not to chose an alternative term.

What if I can't find a term for my product?

Answer

If you can't find a term that is appropriate for your product, you can request a new term on-line. The GMDN Expert Team will review your request and determine if a new term is justified or an existing term may need to be modified or an existing term maybe suitable. When sending a request for a new code, please include as much information about the product as possible. A new term can typically take up to 3 weeks to develop and you will be contacted by the GMDN expert during the development phase as part of the QA process. But please let us know if your need is urgent.

What if I urgently need to register my product and can't find a suitable GMDN Code?

Answer

Regulators and CABs know the process for new term requests used by the GMDN Agency and accept a delay in providing a GMDN Code, provided an application for a new term has already been made.

Can anyone see the GMDN Codes I have chosen?

Answer

All client information contained in the GMDN Database is password protected and not available to any other manufacturer member. Under strict controls we are required to share some client information with Medical Device Regulators, including the identification of GMDN codes selected by manufacturers and which appear in the 'My Terms' list.

Can I see all the GMDN Codes?

Answer

The GMDN Codes are protected so that Users can only find those codes relevant to their product range. This is done by using the GMDN Database search engine to find the most appropriate Preferred Term. From this selection the right GMDN Code. Each Membership criteria provides Users with a limited number of free Code credits, although additional Code Packs can be purchased.

What if I want to share the GMDN access across my organisation?

Answer

Multi-user access is managed within the GMDN database by the 'My User' function, found in 'My GMDN' menu. Multi-site access is managed with an additional Group Membership Licence Agreement - please contact us for more information.

What if I choose the wrong GMDN Code?

Answer

If the User wishes to change the GMDN Code selected for a particular product, it is recommended that the User discusses this with their Regulator or Conformity Assessment Body. Please contact us if you have any concerns.

Is the GMDN available in other languages?

Answer

The reference language of the GMDN is English. Terms and Definitions are translated into many languages and your preference can be chosen from the main menu. The GMDN Agency with the support of Regulators has appointed translators for this special task. The GMDN Database provides translators with a range of facilities, to manage terminology, link the different language versions of the GMDN and support quality control.

Can I find the GMDN Code using an old nomenclature?

Answer

The GMDN Database has a search engine that allows Users to search using codes from those original medical device nomenclatures on which the GMDN was based, such as ECRI (UNDMS), EDMA, FDA (CNMD), ISO (9999), JFMDA & NKKN.