EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as 
regards the assignment of Unique Device Identifiers for contact lenses  
(Text with EEA relevance)    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
In April 2017, the European Parliament and the Council  adopted Regulations (EU) 
2017/745  on medical devices (MDR)  1, aiming to introduce  a new robust, 
transparent, predictable and sustainable regulatory framework for medical devices, 
which ensures a high level of safety, health and innovation.  
One of the main changes from the previous Directi ves2 is the introduction of the 
Unique Device Identification (UDI) system  referred to in Article 27 MDR , aiming to 
ensure  an adequate level of traceability with respect to medical devices and in vitro 
diagnostic medical devices. Basic UDI -DIs, UDI -DIs and UDI-PIs shall be assigned 
(in compliance with the rules of the designated EU issuing entities3), by 
manufacturers to all devices, other than custom -made devices, prior to the placement 
on the market. To further strengthen and enhance traceability and recor ding of UDIs, 
manufacturers shall report Basic UDI -DIs and UDI -DIs in  the European Database on 
Medical Devices (E udamed )4. 
UDI-DI is defined in Part C of Annex VI MDR as the identifier specific to a 
manufacturer and a device . Experience gained through the setting up and 
implementation of the UDI system in the EU and in other jurisdictions  
internationally  shows that certain  devices present  a high level of individualisation  
(‘highly individualised devices’), resulting in  a disproportionate level of granularit y 
and UDI -DIs which would need to be reported in UDI databases  e.g. Eudamed in the 
EU. In comparison with other medical devices, the numerous possible clinical 
parameter combinations  cause a level of granularity not needed for regulatory 
purposes.   
A curre nt example of highly individualised  device s concerned is contact lenses , 
which has been the focus of the discussions both at EU and international level . 
Other jurisdictions that implement a UDI system are faced with the same 
implementation problem  with res pect to contact lenses  but have the possibility to 
grant an exemption to manufacturers of those highly individualised devices, to not 
report the UDI -DIs entries in their UDI Databases.  
The MDR does not provide for the possibility to grant such an exemption  in the EU.  
Therefore, in order to resolve the implementation issue and allow for proportionate 
UDI-DI data entries in Eudamed, the “Master UDI -DI” has been developed by the 
Commission  in close collaboration  with regulators and relevant stakeholders, 
inclu ding industry , contact lenses experts  and EU issuing entities . Master UDI -DI is 
intended as the identifier of a group of highly individualised devices  (i. e. contact 
lenses) presenting specific similarities with respect to defined clinically relevant 
param eters . Whilst in the future the Master UDI -DI solution could be extended to 
                                                 
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/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, 5.5.2017, p. 1. )  
2 Directive 98/79/EC of the European Parliament and of the Council on In Vitro  Diagnostic Medical 
Devices , Council Directive 93/42/EEC  on Me dical Devices , Council Directive 90/385/EEC  on Active 
Implantable Medical Devices .  
3 Entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the 
field of medical devices  as per Commission Implementing Decision (EU) 2019/939 of 6 June 2019 .  
4 As per Article 29 MDR.   
EN 2  EN other highly individualised devices, at present the focus remains on contact lenses.  
Should the need arise, the Commission will propose a new delegated act to extend 
the Master UDI -DI solution to other devices.  
The concept of a UDI -DI grouping several devices is already present in the MDR, 
with respect to system and procedure packs, configurable devices and software5. 
Therefore, the Commission proposes, through a delegated act  to be adopted pursuant 
to Article 27 (10) (b) MDR , an amendment to Part C of Annex VI to Regulation 
(EU) 2017/745, adding a section concerning ‘highly individualised devices’ and 
specifically contact lenses, in order to adapt the UDI -DI assignment criteri a to such 
kind of devices and introducing the “Master UDI -DI” concept.  
2. CONSULTATIONS  PRIOR  TO THE  ADOPTION  OF THE  ACT  
Implementation of the UDI system by industry in the EU began in 2012  on a 
voluntary basis , jointly with other international regulators  at the level of the 
International Medical Device Regulators Forum (IMDRF). The IMDRF UDI 
Working Group (WG) was chaired by the EU. Following the adoption of the MDR, 
the Commission UDI expert group  was established in 2019 , which is  a ‘subgroup ’ of 
the Med ical Devices Coordination Group (MDCG)6, although its predecessor under 
the Directives was also active prior to that time.  
In order to discuss the implementation issue with regards to assignment of UDI -DIs 
to contact lenses, a number of meetings with rele vant stakeholders took place (2019 -
2022), in particular with relevant associations for eyewear products including contact 
lenses, spectacle frames  and ready readers.   
Moreover, meetings with the EU UDI issuing entities on the subject matter took 
place duri ng the course of 2019 -2022 in order to analyse , identify and develop  
possible new solution s to enable technical progress in the field of Unique Device 
identification . 
The EU also discussed  the identified issues for UDI implementation with global 
partners a nd other international Regulators .  
In the MDCG  UDI subgroup , a series of workshops with regulators and stakeholders 
took place in 2020. Proposals from stakeholders were analysed by regulators and the 
Commission, and in 2021  the MDCG  UDI subgroup  agreed to proceed with the 
implementation of the “Master UDI -DI” solution.  
Following the agreement reached at the level of the MDCG UDI subgroup , the 
Commission submitted a request to the EU issuing entities in order to start the work 
for the implementat ion of the  proposed  solution.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
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 
                                                 
5 Annex VI  to MDR, points  6.3 on System and procedure packs , 6.4 on configurable devices and 6.5 on 
Software.  
6 As per Article 103 of the MDR (n. X03565 ). Terms of reference .  
EN 3  EN Eudamed for contact lenses , the Commission is e mpowered to establish a specific 
UDI-DI assignment rule for such devices. This solution will allow for a more 
effective implementation of the UDI system at Union  level.   
EN 4  EN COMMISSION DELEGATED REG ULATION (EU) …/...  
of XXX  
amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as 
regards the assignment of Unique Device Identifiers for contact lenses  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Tre aty on the Functioning of the European Union , 
Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 
5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 
178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC 
and 93/42/EEC1, in particular Article 27(10) , point  (b) thereof , 
Whereas:  
(1) Regulation (EU) 2017/745 provides for a Unique Device Identification ( UDI) system 
for the identification and traceability of dev ices. Before placing a device, other than a 
custom -made device, on the market, the manufacturer is to assign to the device and to 
all higher levels of packaging  of the device  a UDI . The UDI comprises a device 
identifier (UDI -DI) and a UDI production identi fier (UDI -PI). The UDI-DI is one of 
the core elements which a manufacturer needs to provide to the UDI database  in the 
European database on medical devices ( Eudamed ).  
(2) A UDI-DI is to be assigned to a  specific model of device  and manufacturer. Contact 
lenses are available in many variants  due to the  high number of clinical parameters  
that characterise them.  In accordance with Regulation (EU) 2017/745 , an UDI-DI is to 
be assigned to each of such variants  of contact lenses. This individualisation at UDI -
DI level , that results in a proliferation of UDI-DIs to be assigned  to similar contact 
lenses , overwhelm s Eudamed and is  disproportionate compared to the  safety  risk 
associated with contact lenses.  
(3) Taking into account progress at  international level and collaboration with issuing 
entities, concerned industry  stakeholders  and Union competent authorities  for medical 
devices , the technical development in th is field is such that contact lenses  that have the 
same clinical and design parameter combination s are more appropriately grouped  
under the same UDI -DI (Master UDI -DI). In order to avoid assignment of different 
device identifiers to very similar contact lenses, a solution  is therefore needed for 
UDI-DI assignment to contact lenses.  
(4) The Master UDI -DI change  the way in which contact lenses are identified  by making 
the identification less specific . Therefore , to retain an appropriate identification of the 
devices, which includes clinical and design parameters, it is  necessary to  use th e UDI-
                                                 
1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulat ion (EC) No 178/2002 and Regulation (EC) No 
1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC  (OJ L 117, 5.5.2017, p. 1. )  
EN 5  EN PI level  to capture this information. A new UDI-PI type for standard and made to 
order contact lenses  should therefore be introduced . 
(5) Regulation (EU) 2017/745  should therefore be amended accordingly . 
(6) In order to comply with the amendments made by thi s Regulation economic operators 
must  implement changes in their internal systems  and adapt technologies for printing 
and scanning UDI carriers . The application of this Regulation should therefore be 
deferred,  
HAS ADOPTED THIS REGULATION:   
Article 1  
In Part C of Annex VI to Regulation (EU) 2017/745  the following sections are added:  
‘6.6. Highly individualised devices  
6.6.1 Contact lenses  
6.6.1. 1 Standard  contact lenses  
An UDI-DI shall be assigned to standard contact lenses that have 
the same  combination of contact lens design parameters, including 
at least base curve  and diameter  (‘Master UDI -DI’).  
In addition to the requirement laid down in  Section 3.9, a new 
Master UDI -DI shall be required whenever there is a change in the 
combination of the design parameters referred to in  the first 
paragraph.  
In addition to the UDI-PI types listed in Section  1, the UDI-PI 
types for standard contact lenses shall al so include  the following  
contact lens design parameters , where relevant  taking into account  
the characteristics of the lens : 
(a) power ; 
(b) cylinder ; 
(c) axis; 
(d) add power .  
 
6.6.2.1 Made to order contact lenses  
An UDI-DI shall be assigned to made to order contact lenses that 
have the same  combination of contact lens design parameters, 
including at least base curve and diameter (‘Master UDI -DI’).  
In addition to the requirement laid down in  Section 3.9, a new 
Master UDI -DI shall be required whe never there is a change in the 
combination of  the design parameters referred to in the first 
paragraph.  
In addition to the  UDI-PI types  listed in Section 1, the UDI -PI 
types for made to order contact lenses shall also include  an 
Application Identifier indicating that the  contact lens is  a made to 
order  device .  
EN 6  EN  
Article  2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
It shall apply from [date = 2 years from the date of entry into force of this Regulation ].  
However, manufacturers may already before that date assign a Master UDI-DI and UDI -PI in 
accordance with Regulation (EU) 2017/745 as amended by this Regulation.  
This Regulation shall be binding in its entirety . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN