G/TBT/N/EU/963  
30 March 2023  
(23-2222) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  EUROPEAN UNION  
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:   
European Commission  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
European Comm ission,  
EU-TBT Enquiry Point,  
Fax: +(32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
Website: http://ec.europa.eu/growth/tools -databases/tbt/en/  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Certain 
products without an intended medical purpose listed in Annex XVI of Regulation (EU) 
2017/745 on medical devices and standard and m ade to order contact lenses.  
5. Title, number of pages and language(s) of the notified document:  Draft 
Commission Delegated Regulation amending Regulation (EU) 2017/745 of the European 
Parliament and of the Council, as regards the assignment of Unique Dev ice Identifiers for 
contact lenses; (7 page(s), in English)  
6. Description of content:  The proposed Regulation is a Delegated measure adopted 
pursuant to Article 27 (10) (b) of Regulation (EU) 2017/745 whereby the Commission is 
empowered to amend Annex VI  of that Regulation in light of international developments 
and technical progress in the field of Unique Device Identification. In order to resolve the 
implementation issue concerning the registration of UDI -DI data elements in Eudamed 
for highly individua lised devices, and in particular contact lenses, the Commission is 
empowered to establish a specific UDI -DI assignment rule for such devices. This solution 
will allow a more effective implementation of the UDI system at European level.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:   
Commission Regulations (EU) 2017/745 and (EU) 2017/746 introduced the Unique Device 
Identification (UDI) system, aiming at ensuring an adequate level of traceability with 
respect to medical devices and in vitro diagnostic medical devices.  G/TBT/N/EU/963  
 
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  UDI comprises UDI -DIs and UDI -PIs, which shall be assigned (in compliance with the 
rules of the designated issuing entities), by manufacturers to all devices, other than 
custom -made devices , prior to the placement on the market.  
To further strengthen and enhance traceability and recording of UDIs, manufacturers have 
the obligation to report the UDI in Eudamed.  
However, for certain devices characterised by a high level of individualisation (' highly 
individualised devices'), a high variety of types and possible clinical parameters 
combinations would result in the assignment and reporting of a disproportionately high 
number of UDI -DIs for the same device model, with very limited value for regula tory 
purposes.  
The MDR does not provide for the possibility to exempt the manufacturers from the 
obligation of reporting UDI -DIs to Eudamed.  
Therefore, in order to resolve such implementation issue and limit the UDI -DI data entries 
in Eudamed, it is necess ary to elaborate a solution that allows the grouping of highly 
individualised devices presenting specific similarities with respect to defined clinically 
relevant parameters under a same UDI -DI identifier (the 'Master UDI -DI') 
Protection of human health or  safety  
8. Relevant documents:   
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 
on medical devices, amending Directive 2011/83/EC, Regulation (EC) No 178/2002 and 
Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 
93/42/EEC. (OJ L 117, 5.2017, p. 1 -175).  
https://eur -lex.europa.eu/legal -content/EN/TXT/?uri=CELEX%3A32017R0745  
9. Proposed date of adoption:  4th quarter 2023  
Proposed date of entry into force:  The twentieth day following its publication in the 
Official Journal of the EU  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
European Commission,  
EU-TBT Enquiry Point,  
Fax: + (32) 2 299 80 43,  
E-mail: grow-eu-tbt@ec.europa.eu  
The text is available on the EU -TBT Website : http://ec.europa.eu/growth/tools -
databases/tbt/en/  
https://members.wto.org/crnattachments/2023/TBT/EEC/23_8501_00_e.pdf