Obelis European Authorized Representative Center (O.E.A.R.C.)

Regulatory Advice Concerning the Global Medical Device Nomenclature

Obelis s.a. (O.E.A.R.C.) is now offering an invaluable and

essential service to medical device manufacturers regarding the

GMDN (Global Medical Device Nomenclature). O.E.A.R.C. will assist

manufacturers in obtaining their code identification and will

provide assistance for new code submission services.

The Global Medical Device Nomenclature (GMDN) is a comprehensive

system of internationally recognized coded descriptors in the

format of preferred terms with definitions used to generically

identify medical devices and related health care products. It is

used not only in Europe, but also for the most part worldwide as a

means for identifying all medical devices.

The GMDN was founded by Medical Device experts from around the

world (manufacturers, healthcare authorities and regulators) who

compiled the initial GMDN nomenclature based on the standard ISO

15225. The work was mandated by the European Commission in order

to provide the necessary tool to carry out many of the obligations

following the implementation of the Medical Devices Directives.

Also, to meet similar needs at the Global level as identified in

the Global harmonization activities of GHTF by its members, notably

USA (FDA), Canada, European member states, Japan, Australia and now

by many other countries/regions (http://www.gmdnagency.com/


Obelis, with over 19 years of experience and expertise,

hopes to be able to assist manufacturers with these issues

regarding the GMDN. It will continue to add value to its core

services by offering key services such as those mentioned above.

It will also be developing new services and expanding its current

services to meet the demands of manufacturers for the ever growing

global regulations. (www.obelis.net).