Medical Devices       
Medical Devices Coordination Group Document   MDCG  2018 -7   
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MDCG  2018 -7 
Provisional considerations regarding language 
 issues associated with the UDI database  
 (Annex VI, Part A Section 2 and Part B of the 
 Medical Device Regulation (EU) 2017/745 (MDR) 
 and the In -Vitro Diagnostic Medical Device 
 Regulation (EU) 2017/746 (IVDR ))            
  
October  2018  
 
 
  
 
 
This document has been endorsed by the Medical Device Coordination Group 
(MDCG) established by Article 103 of Regulation (EU) 2017/745.  The MDCG is 
composed of representatives of all Member States and it is chaired by a 
representative of the European Commission.  
The document is not a European Commission document and it cannot be regarded 
as reflecti ng the official position of the European Commission. Any views expressed 
in this document are not legally binding and only the Court of Justice of the European 
Union can give binding interpretations of Union law.  
 
  Medical Devices       
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General principles  
In consideration of the following:  
- In accordance with Article 28(3) MDR and Article 25(3) IVDR, the core data 
elements to be provided to the UDI database shall be accessible to the public,  
- Annex VI Part C of the MDR and IVDR on the UDI System requires explicitly in its 
section 5.10 that the user interface of the UDI database shall be available in all 
official languages of the Union and that  the use of free - text fields shall, however, be 
minimized in order to reduce translations,   
-  one of the main declared purposes of th e European database on medical devices 
(Eudamed) as per Recitals 43 -46 and Article 33(1a) of the MDR and Recitals 40 -43 
of the IVDR is to enable the public (including the healthcare professionals) to be 
adequately informed about devices placed on the marke t, 
it is essential that the information in the UDI database is publicly available and easily 
understandable by any European citizen.   
 
Use of free -text and translation  
Among the UDI core data elements of Part B of Annex VI of the MDR and IVDR, only 
three data elements ("Additional product description", "Storage and handling 
conditions" and "Critical warnings or contra -indications") are expected to have a free -
text format, while a fourth data element (nomenclature term) is associated with a text 
allowing to  understand the meaning of the associated code (description).  
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 consi dered 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, in the context of the 
designation procedure for the new nomenclat ure.   
Among the three data elements that use free -text, one is an optional field: "Additional 
product description". It should be provided in English as well as in the languages of 
those countries where the device is made available. A data field will be av ailable for 
each relevant language.  
For the data elements "Storage and handling conditions" and "Critical warnings or 
contra -indications", relevant information (as per Annex I Section 23.2 of the MDR and 
Annex I Section 20.2 of the IVDR: (k) "any special s torage and/or handling 
conditions" and (m) "warning or precautions to be taken") should be provided in  Medical Devices       
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English as well as in the languages of those countries where the device is made 
available. It shall be noted that, as laid down in the provisional guid ance related to 
formats and definitions of UDI data elements, only storage/handling conditions and 
critical warnings or contra -indications, that are required to be on the label, shall be 
transmitted to the UDI database. With respect to those two data eleme nts, the 
possibility to use (in EUDAMED) – as an alternative option - symbols and/or list of 
reference that can categorise and provide enough information understandable by 
anyone is currently being explored.  
 
Indication of hazardous substances (only appli cable for MDR)  
For CMR substances, the Commission intends to explore the feasibility for 
EUDAMED to provide the list of official CMR1 substances (from CLP Regulation2) 
available in the ECHA3 database. The CAS number4, EC number and/or official 
chemical nam e could be used to identify those 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.  
Inform ation to be provided is known by the economic operator in charge of the 
submission as it shall be displayed on the device label (Annex I Section 23.2 (f) of the 
MDR).  
 
                                                            
1 CMR stands for carcinogenic, mutagenic, or toxic for reproduction  
2 Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (the 'CLP 
Regulation')  
3 The European Chemicals Agency  
4 A CAS Registry Number, also referred to as CASRN or CAS Number, is a unique numerical identifier assigned by 
the Chemical Abstracts Service (CAS) to every chemical substance described in the open scientific literature