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Naming a medical device?

Naming medical devices is somewhat of a challenge due to the volume of devices that will claim to do the same thing. Also, the guidelines meaning a device must have an exact name allowing it to become easily identified and linked back to a manufacturer. The importance of having a clear name for marketing and sales purposes is extremely high but a name that is identifiable by legal parties is also important.

The charity for nomenclature (GMDN), the de facto standard for helping manufacturers and hospitals to go through the process of naming a device, is now free.  While you can still choose the chargeable services for fast tracking and other gold standards the fundamental service is now free to all members.

The move is designed to increase the number of members and improve the information held about medical devices. As well as this the move was designed to encourage more small start up manufacturers and innovators to gain membership. There are currently 7000 members, but this is expected to grow significantly.

Without necessarily realising it, naming a medical device can prove quite tricky. The charity GMDN was set up to help its members navigate this regulatory mine field and insure that they have a name that fits and is accurate to the device.

Healthcare product regulators are increasingly insisting all medical device manufacturers use the GMDN. For instance, in such countries as the USA, Australia, UK, Canada and Russia there have been recent announcements by regulators requiring its use.

The GMDN covers all medical devices in all departments of health. They can help businesses with devices in all different parts of the globe and in all parts of health care. It is a step that should make it easier for new innovators get their products to market and become recognisable in the industry. In a time whereby innovation is on every corner and it needs to be.

 

Are you a manufacturer developing an innovative medical device? You will probably need help to protect it. We can help!

Do you have any further questions?

We're here to help.  Call us to speak with one of our experienced advisors:

01902 424 054

Alternatively you can email us, or request a free no obligation insurance review.