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.