Medical device nomenclature for IVD Regulation (EU) 2017/746 and MD Regulation (EU) 2017/745
Posted on 02.04.2019
The European Commission has announced the medical device nomenclature to support the IVDR and MDR implementation. The selected nomenclature is the Italian CND nomenclature, to be mapped to the GMDN nomenclature. The correspondence between the two nomenclatures will be visible to operators and incorporated in the future Eudamed database.
As also announced, the Commission will set up an operative group to provide better regulatory oversight over the EU nomenclature system which includes to settle the structuring principles and the appropriate granularity of the coding.
This is essential provided that the structure and design of the future nomenclature should facilitate the establishment of links with the codes defining Notified Bodies competence (designation scope), the scope of medical devices Quality Management System / Quality Assurance certificates, and product portfolios in the mandate of Authorised Representatives (one generic device group should belong only to one Authorised Representative). A stable nomenclature structure with the appropriate granularity is also a prerequisite for the registration of the Unique Device Identification data elements in the database.