10/20/2011

Obelis O.E.A.R.C.

European Regulators Are Using GMDN

In the past few months, more and more Medical Device Regulators (such as Ministries of Health or National Competent Authorities) have implemented the GMDN codes into their national requirements.

While the use of GMDN Codes will be a requirement for EUDAMED, some European medical device regulators (National Authorities) are already requesting that companies register their products with GMDN codes. Countries such as Poland, Czech Republic, Estonia, Greece and Italy have requested the use of GMDN codes for EUDAMED data-exchange on medical device incidents between Member States. Italy & Portugal request devices to have the respective GMDN codes when completing a Device Registration to their national database while other EU states require the GMDN codes for the Notification of Class I medical devices (MDD 93/42/EEC Article 14.2).

Another example for the use of the GMDN codes can be found by the Turkey Social Security Institute which requested that the current version of GMDN codes will be used by all suppliers when applying for product registration. The Turkey Security Institute is responsible for device expenditure by Turkish hospitals. Suppliers have been given the deadline of May 2011 to supply all necessary information to the national medical device databank (TITUBB).

In spite of the growth in demand of GMDN codes, the costs to obtain such codes are expected to remain unchanged for the year ahead.

In other news – there are now New GMDN Terms for Diagnostics and Therapeutic Radiation Devices.

Please contact us to learn more on how to obtain your GMDN codes.