The General Medical Devices Nomenclature (GMDN)which has been developed based on EN ISO 15225:2000 nomenclature is crucial concerning the European Databank (EUDAMED). GMDN codes are being managed by the GMDN Agency and have the form of a five digit number.
According to the European Commission decision from 19th April 2010, uploading data into EUDAMED requires the use of GMDN codes. Article 4 of the decision states that the EU Member States will ensure that, while entering data into EUDAMED, medical devices will be described using a code from internationally recognized nomenclature for such devices.
The above mentioned article implies that Member States must use GMDN codes while entering data in EUDAMED, and since the responsibility of providing information about the medical device falls on the manufacturers, they are the one who needs to provide the GMDN codes to Competent Authorities or Notified Bodies.
Most importantly, by obtaining the codes from the GMDN Agency, manufacturers’ devices enter EUDAMED, which in itself can be seen as a considerable advantage in the recognition of the devices and their safety thanks to a simpler post market surveillance.
If you wish to know more about GMDN codes, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will gladly be of assistance to you in safeguarding your products’ compliance and answering any questions you may have.
Szymon Nowak-Rogozinski