Date: 2023-10-20Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
This Commission Delegated Regulation (EU) 2023/2197 amends Regulation (EU) 2017/745 regarding the assignment of Unique Device Identifiers (UDI) for contact lenses. It introduces the concept of a "Master UDIDI" to group contact lenses with the same clinical and design parameter combinations under a single UDI. This regulation will apply from November 9, 2025, although manufacturers may implement the Master UDIDI assignment before this date.
**Key Points / Main Content:**
* **UDI System and Contact Lenses:**
* Regulation EU 2017/745 mandates a UDI system for device identification and traceability, requiring a UDI (UDIDI and UDIPI) for devices and their packaging.
* The original requirement led to a proliferation of UDIDIs for similar contact lens variants due to numerous clinical parameters.
* **Master UDIDI Introduction:**
* Contact lenses with the same clinical and design parameter combinations will be grouped under a single "Master UDIDI."
* The combination of design parameters must include at least base curve and diameter.
* A new Master UDIDI is required whenever there is a change in the combination of these design parameters.
* **Application and Enforcement:**
* The regulation comes into force on the twentieth day following its publication in the Official Journal of the European Union.
* It applies from November 9, 2025.
* Manufacturers can voluntarily adopt the Master UDIDI assignment before the official application date.
**Impact Analysis:**
**Manufacturers:**
* *Impact:* Simplifies UDI assignment for contact lenses by using Master UDIDIs, potentially reducing the number of unique identifiers needed. Requires changes to internal systems and adaptation of technologies for UDI carriers.
* *Action Required:* Implement changes in internal systems and adapt technologies for printing and scanning UDI carriers, aligning with the Master UDIDI concept by November 9, 2025.
**Economic Operators:**
* *Impact:* Must comply with the amended UDI assignment rules for contact lenses.
* *Action Required:* Adapt to the new Master UDIDI system for contact lenses and ensure compliance by the application date.
**European database on medical devices (Eudamed):**
* *Impact:* Eudamed will be less overwhelmed by the number of UDIDIs to be assigned to contact lenses.
* *Action Required:* No action required.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Regulation (EU) 2017/745: A regulation of the European Parliament and of the Council on medical devices.
European Parliament: One of the legislative branches of the European Union.
Council of the European Union: A legislative body of the European Union comprising government ministers from each member state.
Unique Device Identifier (UDI): A system for the identification and traceability of medical devices.
Eudamed: The European database on medical devices.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the day-to-day business of the EU.
Brussels: The de facto capital city of the European Union, located in Belgium.
Official Journal EN
of the European Union L series
2023/2197 20.10.2023
COMMISSION DELEGATED REGULATION (EU) 2023/2197
of 10 July 2023
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 Treaty 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 2017on 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(1), 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 devices. 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 production identifier (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, overwhelms
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 this field is such
that contact lenses that have the same clinical and design parameter combinations 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) Regulation (EU) 2017/745 should therefore be amended accordingly.
(5) In order to comply with the amendments made by this 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
(1) OJ L 117, 5.5.2017, p. 1.
ELI: http://data.europa.eu/eli/reg_del/2023/2197/oj 1/2EN
OJ L, 20.10.2023
6.6.1.1. Standard contact lenses
A 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.
6.6.1.2. Made to order contact lenses
A 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 whenever there is a
change in the combination of the design parameters referred to in the first paragraph.’
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 9 November 2025.
However, manufacturers may already before that date assign a Master UDI-DI in accordance with Regulation
(EU) 2017/745 as amended by this Regulation.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 July 2023.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/reg_del/2023/2197/oj