REGULATORY INFORMATION
SUBJECT: MD-IVDMD Regulations / News on the EUDAMED database
PERSONS CONCERNED: Regulatory Affairs and Quality Managers
COMPANIES CONCERNED: MD Companies
Regulatory CONTEXT
The European regulations on MD (Article 33) and INVMD (Article 30), which will come into force in 2020 and 2022 respectively, anticipate the implementation, maintenance and management of Eudamed, the European database on medical devices, by the Commission, after consultation with the Medical Device Coordination Group (MDCG – comprising one representative per Member State and presided over by the Commission).
ANALYSis
- Publication of the functional specifications of Eudamed – February 2019
The European Commission published version 4.1 of the technical specifications of Eudamed, the database introduced by the MD Regulation, which is expected to go live in March 2020.
Draft Functional specifications for the European Database on Medical Devices (Eudamed) –
First release (High(1)) to be audited
First draft consolidated version of functional specifications for Eudamed (version 4.1)
The document presents, in the form of a table, the functions that Eudamed must offer in relation to the obligations of the various participants (manufacturers, competent authorities, etc.) resulting from the Regulations.
- Publication document relating to the reference nomenclature – March 2019
On 4 March 2019, the European Commission published a document relating to the medical device nomenclature.
“In accordance with articles 26 and 23 of the MD and IVDMD Regulations, given the points of view expressed by the MDCG, the CND nomenclature, to be combined with the GMDN nomenclature, will be made available in the future Eudamed.
Correspondence between nomenclatures will be visible to operators and integrated in the future database. This will enable all operators registering their device to find a CND nomenclature equivalent to a GMDN code. To strengthen regulatory surveillance of the EU nomenclature system, a sub-group of the Medical Device Coordination Group (MDCG) will soon be created”.
The future European medical device regulation requests that the European Commission facilitate the operation of the EUDAMED database, to ensure that manufacturers and other natural persons or legal entities obliged to use the medical device nomenclature, have free access to an internationally recognised medical device nomenclature.
Taking due account of the points of view of the interested parties, the European Medical Device Coordination Group (MDCG) anticipates the use of the Italian nomenclature codes (CND) as the basis of the Eudamed database device nomenclature. The CND nomenclature will be mapped to the global medical device nomenclature (GMDN).
Link to the CND (“Classificazione Nazionale dei Dispositivi medici”) nomenclature:
(Translated into English – updated 13.3.18):