Date: 2026-06-17Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2026/1313 of 15 June 2026 amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary**
Commission Implementing Decision (EU) 2026/1313, adopted on 15 June 2026, updates the harmonised standards for symbols used with in vitro diagnostic medical devices under Regulation (EU) 2017/746. It introduces amendment EN ISO 15223-1:2021/A1:2025 to reflect technical and scientific progress, specifically regarding authorized representative terminology and symbols. While the decision enters into force immediately, a five-year transition period is provided, with the previous standard reference set for withdrawal on 17 June 2031.
**Key Points / Main Content**
**Standardization Updates**
* **Adoption of Amendment:** The decision incorporates amendment EN ISO 15223-1:2021/A1:2025 into the list of harmonised standards for medical device symbols.
* **Term Definitions:** The amendment adds a specific defined term for "authorized representative."
* **Symbol Modification:** The "EC REP" symbol has been modified to be non-country and non-region specific.
* **Presumption of Conformity:** Devices complying with these updated harmonised standards are presumed to meet the corresponding requirements of Regulation (EU) 2017/746.
**Regulatory Amendments**
* **Annex Update:** Entry No 8 in the Annex to Implementing Decision (EU) 2021/1195 is deleted and replaced by entry No 8a, which includes the new amendment.
* **Effective Date:** The Decision enters into force on the date of its publication in the *Official Journal of the European Union* (17 June 2026).
**Transition and Deferral**
* **Withdrawal Deferral:** The withdrawal of the previous version of the harmonised standard is deferred for five years to allow economic operators sufficient time to adapt.
* **Implementation Deadline:** The deletion of the old standard reference (Point 1 of the Annex) applies from 17 June 2031.
**Impact Analysis**
**Manufacturers and Economic Operators**
**Impact**
These stakeholders face significant impacts regarding the costs and timing required to implement labeling changes across manufacturing and distribution chains at both EU and international levels.
**Action Required**
Operators must adapt their manufacturing processes and update device labeling to align with the modified "EC REP" symbol and updated terminology before the June 2031 deadline.
**CEN and CENELEC (Standardization Bodies)**
**Impact**
These bodies were responsible for revising existing standards to align with the Commission's request and ensuring the amendments satisfy the requirements of Regulation (EU) 2017/746.
**Action Required**
Maintain the standards and ensure that the revised EN ISO 15223-1:2021/A1:2025 is properly referenced and accessible for industry use.
Key Entities Referenced
Regulation (EU) 2017/746: The primary European Union regulation on in vitro diagnostic medical devices which these harmonised standards are designed to support.
EN ISO 15223-1:2021: The harmonised standard for symbols used in medical device labeling, updated by amendment A1:2025 to include new terms and representative symbols.
Implementing Decision (EU) 2021/1195: The specific legislative document that lists harmonised standards for in vitro diagnostic medical devices, which is amended by this decision.
Medical Device Coordination Group (MDCG): The expert advisory body whose standards subgroup provided the impact assessment used to determine the five-year transition period for manufacturers.
Official Journal EN
of the European Union L series
2026/1313 17.6.2026
COMMISSION IMPLEMENTING DECISION(EU) 2026/1313
of 15 June 2026
amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols
to be used with information to be supplied by the manufacturer
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on
European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC,
95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament
and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European
Parliament and of the Council(1), and in particular Article 10(6) thereof,
Whereas:
(1) In accordance with Article 8(1) of Regulation (EU) 2017/746 of the European Parliament and of the Council(2),
devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the
references of which have been published in the Official Journal of the European Union, are to be presumed to be in
conformity with the requirements covered by those standards or parts thereof set out in that Regulation.
(2) By Implementing Decision C(2021) 2406(3), the Commission made a request to the European Committee for
Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) for the revision
of existing harmonised standards on in vitrodiagnostic medical devices developed in support of Directive 98/79/EC of
the European Parliament and the Council(4)(‘the request’).
(3) On the basis of the request, CEN and CENELEC revised the harmonised standard EN ISO 15223-1:2021 on symbols
to be used with information to be supplied by the manufacturer, the reference of which is published in the Official
Journal of the European Union in support of Regulation (EU) 2017/746, in order to take into account the latest
technical and scientific progress.
(4) The revision of this standard resulted in the adoption of the amendment EN ISO 15223-1:2021/A1:2025 on
addition of defined term for authorized representative and modified EC REP symbol to not be country or region
specific (‘the amendment’).
(5) The Commission has assessed, together with CEN and CENELEC, whether the amendment complies with the request.
(6) The amendment satisfies the requirements which it aims to cover, and which are set out in Regulation
(EU) 2017/746. It is therefore appropriate to publish the reference of the amendment in the Official Journal of the
European Union.
(1) OJ L 316, 14.11.2012, p. 12, ELI: http://data.europa.eu/eli/reg/2012/1025/oj.
(2) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitrodiagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176, ELI: http://data.europa.eu/eli/reg/
2017/746/oj).
(3) Commission Implementing Decision C(2021) 2406 of 14 April 2021 on a standardisation request to the European Committee for
Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation
(EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation
(EU) 2017/746 of the European Parliament and of the Council (https://ec.europa.eu/growth/tools-databases/enorm/mandate/575_en).
(4) Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
(OJ L 331, 7.12.1998, p. 1, ELI: http://data.europa.eu/eli/dir/1998/79/oj).
ELI: http://data.europa.eu/eli/dec_impl/2026/1313/oj 1/3EN
OJ L, 17.6.2026
(7) The Annex to Commission Implementing Decision (EU) 2021/1195(5)lists the references of harmonised standards
for in vitrodiagnostic medical devices drafted in support of Regulation (EU) 2017/746.
(8) As the harmonised standard EN ISO 15223-1:2021 has been amended, the reference to its previous version should
be deleted from the Annex to Implementing Decision (EU) 2021/1195.
(9) Implementing Decision (EU) 2021/1195 should therefore be amended accordingly.
(10) In order to give manufacturers and other economic operators sufficient time to adapt their processes and devices that
are covered by the harmonised standard EN ISO 15223-1:2021, it is necessary to defer the withdrawal of the
reference of that harmonised standard, to allow for a period of 5 years, as information provided by the sectorial
interested parties in the Subgroup of Standards of the Medical Device Coordination Group shows the significant
impact on economic operators in terms of costs and timing to implement labelling changes in manufacturing and
distribution of devices, taking into account the processes involved, both at EU and international levels(6).
(11) Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential
requirements set out in Union harmonisation legislation from the date of publication of the reference of such
standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its
publication,
HAS ADOPTED THIS DECISION:
Article 1
The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.
Article 2
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
Point (1) of the Annex shall apply from 17 June 2031.
Done at Brussels, 15 June 2026.
For the Commission
The President
Ursula VON DER LEYEN
(5) Commission Implementing Decision (EU) 2021/1195 of 19 July 2021 on the harmonised standards for in vitrodiagnostic medical
devices drafted in support of Regulation (EU) 2017/746 of the European Parliament and of the Council (OJ L 258, 20.7.2021, p. 50,
ELI: http://data.europa.eu/eli/dec_impl/2021/1195/oj).
(6) See the documents related to the meeting of the Subgroup on Standards of the Medical Device Coordination Group, held on
4 February 2026: https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=69791.
2/3 ELI: http://data.europa.eu/eli/dec_impl/2026/1313/ojEN
OJ L, 17.6.2026
ANNEX
The Annex to Implementing Decision (EU) 2021/1195 is amended as follows:
(1) entry No 8 is deleted;
(2) the following entry is inserted:
‘8a. EN ISO 15223-1:2021
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General
requirements (ISO 15223-1:2021)
EN ISO 15223-1:2021/A1:2025’.
ELI: http://data.europa.eu/eli/dec_impl/2026/1313/oj 3/3