European Commission: CND replaces GMDN for DM nomenclature
2019-03-06 EU Com release
The European Commission published on March 4, 2019, a document on the nomenclature of medical devices.
It follows the description of the functionalities required for this nomenclature, which was the subject of document MDCG 2018-2 (9 April 2018).
_ The surprise is that the GMDN ("Global Medical Device Nomenclature") was not finally selected by the European Commission: it is the CND ("Classificazione Nazionale dei Deviceivi medici"), a nomenclature established by the Italy, which will be used.
Hold on: the site is only available in Italian !
On this site, there is an English version of this nomenclature "CND", but it is a version that dates from 2016, not the latest version of March 2018, which is in Italian only.
The 2016 CND nomenclature is available in PDF format (132 pages) or as an Excel file and 6986 lines.
The European Commission has announced that it will be interfaced with the GMDN nomenclature and will be made available in the future EUDAMED database.
(For the record, Health Canada has adopted the GMDN nomenclature since May 22, 2018.)
Attached are :
The 2016-06-08 Italian-English CDN database version; The 2019-02-28 EU Com release about EUDAMED _Draft for its functional specifications ; and of course, the 2019-03-04 EU com decision about EUDAMED _ Italian Code Chosen for MD_nomenclature_ (English)
Hoping these will be helpful to you,
With our best regards, MediMark Europe teams_
