Executive Summary:
Commission Delegated Regulation (EU) 2025/788 amends Delegated Regulation (EU) 2023/2197, concerning the assignment of Unique Device Identifiers (UDI) for contact lenses using the Master UDI-DI solution. The amendment defers the application date of Regulation (EU) 2023/2197 by one year to November 9, 2026. This delay is due to the need for operators to implement guidance and adapt systems for UDI assignment.
Key Points / Main Content:
* **Amendment:**
* Regulation (EU) 2025/788 amends Delegated Regulation (EU) 2023/2197.
* **Date of Application Deferral:**
* The application date of Delegated Regulation (EU) 2023/2197 is deferred from November 9, 2025, to November 9, 2026.
* **Reason for Deferral:**
* The deferral is to allow operators adequate time to implement the Master UDI-DI solution for contact lenses.
* Operators need time to adapt internal systems and technologies for UDI assignment.
* The deferral ensures legal certainty and a smooth transition.
* **Entry into Force:**
* Regulation (EU) 2025/788 enters into force twenty days after its publication in the Official Journal of the European Union.
Impact Analysis:
* **Manufacturers/Operators of Contact Lenses:**
* *Impact:* Have an additional year to implement the Master UDI-DI solution and adapt systems.
* *Action Required:* Utilize the provided guidance document MDCG 2024-1 to plan implementation efforts, allocate resources, and adapt internal systems for UDI assignment, ensuring compliance by November 9, 2026.
* **Medical Device Coordination Group (MDCG):**
* *Impact:* The MDCG's guidance document on the implementation of the Master UDIDI solution for contact lenses is now aligned with the revised application date.
* *Action Required:* Continue to support and monitor the implementation of the Master UDIDI solution for contact lenses, providing further guidance as needed.
* **European Commission:**
* *Impact:* Responsible for ensuring the effective and harmonized implementation of the Master UDIDI solution for contact lenses across member states.
* *Action Required:* Monitor the implementation of the amended regulation and address any issues that may arise.
* **Member States:**
* *Impact:* Must apply the amended regulation.
* *Action Required:* Ensure the regulation is directly applicable within their jurisdiction.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
Treaty on the Functioning of the European Union: One of the primary treaties forming the constitutional basis of the European Union.
Regulation EU 2017/745: A European Union regulation on medical devices.
Directive 2001/83/EC: A European Union directive relating to medicinal products for human use.
Regulation EC No 178/2002: A European Union regulation laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
Regulation EC No 1223/2009: A European Union regulation on cosmetic products.
Commission Delegated Regulation EU 2023/2197: A European Union regulation amending Regulation EU 2017/745 as regards the assignment of Unique Device Identifiers (UDI) for contact lenses.
Official Journal EN
of the European Union L series
2025/788 28.7.2025
COMMISSION DELEGATED REGULATION(EU) 2025/788
of 16 April 2025
amending Delegated Regulation (EU) 2023/2197 as regards the date of application
(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 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(1), in particular Article 27(10), point (b), thereof,
Whereas:
(1) Commission Delegated Regulation (EU) 2023/2197(2) amended Regulation (EU) 2017/745 as regards the
assignment of Unique Device Identifiers (UDI) for contact lenses as highly individualised devices, by introducing the
‘Master UDI-DI’ solution. Delegated Regulation (EU) 2023/2197 is to apply from 9 November 2025.
(2) The Subgroup on Unique Device Identification of the Medical Device Coordination Group (MDCG) established by
Article 103 of Regulation (EU) 2017/745 identified a need to develop guidance to ensure effective and harmonised
implementation of the Master UDI-DI solution for contact lenses.
(3) The MDCG endorsed guidance document MDCG 2024-1 ‘Guidance on the implementation of the Master UDI-DI
solution for contact lenses’. The Commission published that guidance document on its website in November
2024(3), one year before the date of application of Delegated Regulation (EU) 2023/2197.
(4) Given the clear need for availability of that guidance document for operators to plan their implementation efforts and
resource allocation on such complex technical matter, in order to allow them to adequately implement the Master
UDI-DI solution for contact lenses and adapt their internal systems and technologies for UDI assignment, as well as
to ensure the necessary level of legal certainty on the market and a smooth transition to the new rules, it is
appropriate to defer the date of application of Delegated Regulation (EU) 2023/2197 by one year.
(5) Delegated Regulation (EU) 2023/2197 should therefore be amended accordingly,
HAS ADOPTED THIS REGULATION:
Article 1
In Delegated Regulation (EU) 2023/2197, Article 2, the second paragraph is replaced by the following:
‘It shall apply from 9 November 2026.’.
(1) OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj.
(2) 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 (OJ L, 2023/2197, 20.10.2023, ELI:
http://data.europa.eu/eli/reg_del/2023/2197/oj).
(3) https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf.
ELI: http://data.europa.eu/eli/reg_del/2025/788/oj 1/2EN
OJ L, 28.7.2025
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 16 April 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/reg_del/2025/788/oj