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 
Commi ssion.  
 
The document is not a European Commission document and it cannot be regarded as 
reflecting 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.  
 
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MDCG 2018 -2 
Future EU medical device nomenclature   
Description of requirements                                                                                                                                                                                                                                             
 
Introduction  
 
According to Article 26 of the Regulation 745/2017 on medical devices and Article 23 
of Regulation 746/2017  on in-vitro diagnostic medical device , the Commission is 
required to make available a medical device nomenclature to support the functioning 
of the future  EUDAMED . 
 
This document intends to provide a detailed description of requirements and criteria 
that the future nomenclature is expected to fulfil. This is expected to serve as a 
reference basis throughout the decision process and will also ensure th at all legal 
and technical issues associated with the future EU medical device nomenclature are 
properly mapped.  
 
 
1. Description of legal requirements  
 
It arises from the text of the new Regulations (namely Article 26 of Regulation 
745/2017 and Article 23 of Regulation 746/2017) that t he future EU medical device 
nomenclature  will have to comply with certain defined requirements . 
 
First of all, t he future nomenclature shall be available free of charge to 
manufacturers and other natural o r legal persons required by the  Regulation to use 
that nomenclature, this meaning that no manufacturer or natural/legal person should 
be subject to fee or suffer from any discrimination, compared to other operators, in 
relation to the use of the nomenclature under the new Medical Device Regulations.  
 
It shall be therefore ensured that relevant names and codes are accessible (in full) in 
EUDAMED to all operators that are requested to provide the relevant UDI 
submissions.  
 
Provisions in Chapter III and Annex VI of the new Regulations, and in particular  the 
combination of Article 28( 3) of the Regulation 745/2017 on medical devices and 
point 8 of part B of Annex VI , provide that moreover names and codes are publicly 
availabl e in the UDI database (in EUDAMED ).  
 
By virtue of Article 26, t he Commission shall a lso endeavour to ensure that the  
nomenclature is available to other stakeholders free of charg e, where reasonably 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 
Commi ssion.  
 
The document is not a European Commission document and it cannot be regarded as 
reflecting 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.  
 
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 practicable. The public availability of terms and codes in EUDAMED is in itself an 
ideal vehicle to provide sufficient access of all stakeholders .   
 
Finally the nomenclature shall be internationally recognised at the time of the date of 
application of the Regulations. In this context, global harmonisation principles and 
orientations followed and adopted by  the International Medical Device Regulators 
Forum  (IMDRF)  and the World Health Organisation , are taken into particular 
account .  
 
Without prejudice to the fulfilment of requirements d escribed in previous paragraphs, 
the European Commission and the Competent Authorities  from EU Member States  
shall benefit from the full access to the most up to date nomenclature system  and its 
hierarchies  free of charge . They shall not be charged  for any service received from 
the nomenclature provider, which is necessary for them to exert their supervisory 
role over the nomenclature and the fulfilment of their obligations under the new 
Regulations.   
 
2. Description of other relevant criteria  
 
In order for the system to leverage further the potential of the future EU 
nomenclature, some other essential requirements that the nomenclature shall fulfil  
have been identified .  
 
While those requirements are not explicitly mentioned in the texts of the two  
Regulation s, they are  essential to guarantee the good functioning of the future 
EUDAMED  and to the fulfilment of some of the regulatory objectives set in the new 
Regulation s, namely facilitating effective market surveillance  operations  and 
facilitating  device traceability throughout the supply chain.  
 
Policies/rules for update, removal  and creation of names  and descriptions  in the 
nomenclature are to be sound and must reflect regulators ’ and the wider healthcare 
economy needs . An EU regulatory team on no menclature  composed of regulators , to 
be established possibly  as an MDCG sub -group , will review, determine (preferably 
within a global perspective) and validate those rules prior to designation decision and 
will continue to hold an advisory role on these matters . On a  periodic basis, in 
accordance with a pre -defined procedure, and in consultation with the nomenclature 
provider, that group shall also provide feedback and advice on the governance  of 
terms and descriptions, based, inter alia, on the requests received from economic 
operators and other stakeholders.  
 
In the context of activities mentioned in the previous paragraph, it shall be aimed to 
ensure that the terminology structure used for it should not be unnecessarily  granular  
and should not contain names that are only used by only a few  economic operators 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 
Commi ssion.  
 
The document is not a European Commission document and it cannot be regarded as 
reflecting 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.  
 
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 or stakeholders , unless it is proven to be advantageous to regulators or the wider 
healthcare economy.  
 
The structure and design of the future nomenclature should facilitate the 
establishment of lin ks with the codes defining N otified Bodies  competence 
(designation scope) , the scope of medical device s QMS  (Quality Management 
System)/QA (Quality Assurance)  certificates , and product portfolio s in the mandate  
of Authorised Representatives .   
 
The nomenclature should have hierarch ies by which terms and codes could be 
meaningfully grouped  into categories and subcategories   
 
The future nomenclature system shall adequately support the functioning of the 
EUDAMED database and the functioning of the new Regulations as a whole. In this 
context, EUDAMED shall make available the most updated names/codes related 
information, to the be nefit of operators and general public. Therefore, the 
nomenclature provider will need to have procedures and services in place that shall 
allow E UDAMED  to be kept up -to-date at any time.  When setting the procedure, in 
particular the frequency, related to the periodic review of nomenclature terms and 
descriptions , this shall be taken into account.  
 
For enforcement purposes , in relation to its obligations vis -à-vis the Commission and 
the EU economic operators, the nomenclature provider  shall have a legal entity in 
either one of the EEA countries  or Switzerland  or Turkey1 with an exception being 
foreseen for international organisations in which the EU is one of the members .   
 
System/processes shall be in place to periodically  review the terminology structure 
and content to incorporate learning from ongoing experience with real -world use of 
device nomenclature (ex. EUDAMED, GUDID, registries)  as well as from 
technological  innovation . 
 
Availability of names and descriptions in all the official EU langu ages is recognised 
as of being of high importance.  
 
All copyright s associated with the nomenclature shall be secured.  
                                                       
1 Indication of these countries is based on current situation with the applicable directives on medical devices 
as a result of the combination of the legal text of those Directives and relevant currently applicable 
international agreements . this list of countries might be subject to change in the context of the new m edical 
device framework.