| Theme | EUDAMED – UDI database |
| Target audience | Manufacturers |
| Products concerned | MD, IVD |
| Regulatory references | MDR (EU) 2017/745
Article 28(3) Annex VI part C section 5.10 Article 33(1a) Recitals 43-46 IVDR (EU) 2017/746 Article 25(3) Annex VI part C section 5.10 Recitals 40-43 |
| Documents mentioned | Regulation (EC) No 1272/2008 (CLP) |
This guide concerns the languages to be used to register devices in the EUDAMED UDI database. Of the items provided to the UDI database, only three data elements (additional product description (optional), storage and/or handling conditions and critical warnings or contraindications) are expected to be in free text format. The MDCG specifies that these elements must be submitted in English as well as in the languages of the Member States where the device is made available.
As to the nomenclature, ideally, all the terms/description associated with the nomenclature codes should be translated in the different Union official languages. However, it could be also considered having terms available only in English, particularly taking into account that the nomenclature will have a code. Appropriate budget and legal verifications will be made on this matter.
Finally, the document states that for CMR substances, the Commission intends to explore the feasibility for EUDAMED to provide the list of official CMR substances available in the ECHA database. The CAS number, the EC number and/or the official chemical name should be used to identify these substances. With regard to endocrine disruptor substances, pending verification that an official database managed by the Commission containing these substances is available, a solution is currently being explored.