The implementation of the EUDAMED database continues to make good progress, and existing specifications are being further elaborated and adapted accordingly.
The timelines for the mandatory establishment of the EUDAMED system for the reporting of economic operators with medical devices - i.e. manufacturers, importers, authorized representatives and distributors - are becoming more specific, but there are also further postponements of the originally planned timelines in various aspects. According to the latest information, the system is expected to be fully operational in the second half of 2023, at which point the six-month transition period to establish the system will become mandatory.
The introduction and updating of computerized systems in a QM system, such as automatic or semi-automatic interfaces to the online database system, require detailed planning, including a precise specification analysis. Experience shows that such a project can hardly be realized within six months; the provision of sufficient resources is a minimum enabler for such a project.
In order to ease these deadlines, the EU Commission is continuously developing various guidance documents which should be considered during the implementation of the system in order to enable a smooth transition to the new EUDADMED system.
Over the summer, technical specification documents in particular were published in this project, to which we would like to refer you in this context:
- UDI device data dictionary
- M2M data exchange services definition
- Service entity model XSD
- xml samples
An overview of the guidance documents in the EUDAMED project is also available online at: https://ec.europa.eu/health/md_eudamed/overview_en
Additionally we may also remind refer o the MDCG guidance documents on the EUDAMED system:
Reference | Title |
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR | |
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional | |
MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States | |
Registration of legacy devices in EUDAMED | |
Timelines for registration of device data elements in EUDAMED |