DTA Meeting with MHRA – Member Queries Answered
By DTA | 28th April 2022 | News
If you manufacture custom-made dental appliances including fixed bridges, crowns, splints, or retainers etc., you are required to register with the MHRA as a manufacturer of custom-made dental devices under MDR and to provide your business address and a description of the devices you produce.
The DTA had a meeting with MHRA to discuss our most common member queries.
We were informed that there is a free to access step-by-step video that demonstrates exactly how you should register your dental devices. A link to this tutorial video can be found on the DTA website, at the bottom of the MHRA page, visit https://www.dta-uk.org/mhra-mdr.
MHRA has confirmed that you do not need to register with the Global Medical Device Nomenclature (GMDN) unless you want to register your own GMDN codes. There are an overwhelming number of GMDN codes, however there is a search facility to help you find the code you need. Just type in as many terms to describe your devices as possible and this will help whittle the codes down to those most relevant to your lab's workflow.
MHRA suggested that you should select the codes that best represent your devices and once you have done so you can log these within your MHRA registration statement.
Your statement only needs one particular GMDN code for a specific device. There are a number of similar codes that seem to be for the same device. Choose just one code to represent the type of device you are manufacturing. Your MHRA statement only needs one GMDN code to cover each particular device, so use whichever code is most suitable for each device.
MHRA has also assured the DTA that it always does its best to respond to every query it receives, but this may take some time. You could be waiting a week or two before you receive a response so please be patient.