Answers to frequently asked questions.
- What is the GMDN?
- 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 owned and managed by the GMDN Agency.
- How can I get a GMDN Code for my product?
- Only GMDN Membership can give you access to the GMDN Codes. The GMDN Agency is a registered charity. The Agency is managed by a Board of Trustees and Policy Advisory Group which represent medical device Regulators, manufacturers and healthcare providers. Fees for membership are reviewed each year by our Board 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?
- No, the GMDN Agency is not a Medical Device Regulator. We make available the generic GMDN Terms to improve the consistency of naming medical devices. This improves communication within the health-sector and helps Regulators better understand information concerning medical device safety.
- Do all manufacturers need to find GMDN Codes for their products?
- 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. In the USA the FDA have introduced the use of the GMDN as part of their UDI Rule. The medical device Regulators in over 90 countries are using the GMDN to support patient safety and beginning to require the use of the GMDN Code in their medical device listing / approval process.
- What is the difference between a GMDN Term and a GMDN Code?
- The GMDN Term is made up of several data elements, including the Term Name, GMDN Code and a Definition. As seen in this example:
- Term Name: 'General-purpose syringe'
- GMDN Code: '47017'
- Definition: 'A sterile device consisting of a calibrated barrel (cylinder) with plunger...'.
Using the GMDN Database users can search all the Term Names and Definitions for the most appropriate description of their product. Once selected, the GMDN Code is made available to the User and then used for regulatory listing or data exchange purposes. Selected Codes are automatically added to the users 'My Terms' list for your future reference and the GMDN Agency monitors these and sends notifications if the status changes.
- How often are new GMDN terms issued?
- New terms are issued frequently following requests from Users who are developing new technology or due to feedback from medical device Regulators. The GMDN Database is updated daily. Members are informed by email if a term in their 'My Terms' list is modified or made obsolete.
- What if my GMDN term is modified by the GMDN Agency?
- A GMDN Term Name or Definition may need to be modified to expand its scope or the Term may be made obsolete if it no longer accurately represents product group. Registered Members with these particular Terms in their 'My Terms' list will be notified automatically by email, so that they can consider whether or not to chose an alternative Term for their product.
- What if I can't find a term for my product?
- If you can't find a term that is appropriate for your product, you can request assistance from the GMDN Agency. We have a free on-line enquiry service that will review your product and the relevant existing GMDN terms. The GMDN Agency 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 an enquiry, please include as much information about the product as possible. The enquiry process is complex and can take several weeks to complete, so please give us plenty of time to consider your enquiry. 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?
- 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?
- 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?
- The GMDN Codes are protected so that Users can only see codes relevant to their product range. This is done by the User searching the GMDN database until they find the most appropriate GMDN Term for their product. Users can see all 23,000+ GMDN Terms in the database. The User can then use a Code Credit to reveal the related GMDN Code (this is a 5-digit number). The GMDN Term is then automatically added to the Users 'My Terms' list, for future reference. Each Membership criteria provides Users with a limited number of free Code Credits when they join, although additional Code Packs can be purchased at any time.
- What if I want to share the GMDN access across my organisation?
- Multi-user access is managed within the GMDN database by the 'Users' function, found in 'Account' menu. The Users function is restricted to users with a specific permission on their GMDN account - please contact us for more information.
- What if I choose the wrong GMDN Code?
- 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. If users no longer want us to monitor a Term in the their 'My Terms' list, this can be moved to their 'My Archive' list.
- Is the GMDN available in other languages?
- 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.
- How long does it take to develop a GMDN term?
- There are several aspects to term development: 1) Request assessment and assignment – about 4 – 7 days; 2) Additional information gathering - depends on timeliness of manufacturer’s response; 3) Processing and quality control - 7 – 10 days depending on complexity of existing terms in the device area; 4) Requestor approval - depends on timeliness of manufacturer’s response; 5) Finalising term - 1 day (the 14 day public review period may be selected by some manufacturers).
- When a GMDN term is modified or made obsolete will I have to reallocate the UDI on my product and re-label?
- GMDN code is not built into the Static UDI number allocated to your product and therefore changes to GMDN terms will not require you to assign a new UDI to your product and the costly relabelling that would result.
As part of their implementation of UDI, the US FDA require manufacturers to submit a GMDN Code that is not obsolete, when you provide your product information as part of the GUDID record submission. We have been informed by the FDA that it is possible to change the GMDN Code allocated to a product on the GUDID at any time, because the GMDN record is not ‘locked’ unlike other information, such as the Static UDI number.
- If a product has a GMDN Code is it a Medical Device?
- If a product has been assigned a GMDN Code it is not necessarily a medical device. Please refer to the regulation that applies to medical devices in your country of interest. It is envisaged that the use of the GMDN by all countries will support the harmonisation of the definition of a medical device worldwide.
- Who is the GMDN Agency?
- Since 1991 Medical Device experts from around the world (regulators, healthcare providers and manufacturers) have compiled the Global Medical Device Nomenclature (GMDN). This work was requested by the inter-governmental body, the Global Harmonisation Task Force (GHTF) to help accelerate international medical device regulatory harmonization and convergence. The GHTF has now been superseded by the IMDRF (see www.imdrf.org).
To manage the GMDN, a non-profit maintenance agency was required. The GMDN Agency manages a membership scheme to sustain the ongoing maintenance of the GMDN.