Commission Implementing Regulation (EU) 2026/2096 of 18 September 2026 establishing procedures for the operation of the network for epidemiological surveillance

Official Journal EN of the European Union L series 2026/2096 21.9.2026 COMMISSION IMPLEMENTING REGULATION(EU) 2026/2096 of 18 September 2026 establishing procedures for the operation of the network for epidemiological surveillance (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU(1), and in particular Article 13(10), point

(c), thereof,

Whereas:

(1) In accordance with Regulation (EC) No 851/2004 of the European Parliament and of the Council(2)establishing a European centre for disease prevention and control (‘ECDC’), the ECDC operates dedicated networks on surveillance (‘dedicated networks’) which together constitute the network for epidemiological surveillance referred to in Article 13 of Regulation (EU) 2022/2371. Since the activities of the dedicated networks form the foundation for communicable disease surveillance and ultimately prevention and control at Union level, the procedures for their operation should be effective, efficient and consistent across networks.

(2) In accordance with Article 5(4) of Regulation (EC) No 851/2004, the dedicated networks consist of national focal points or operational contact points designated by national coordinators on behalf of national coordinating competent bodies. The procedures should therefore take these different roles into account when detailing their responsibilities.

(3) Regular contacts and exchanges foster coordination and improve surveillance at the Union level. They offer the opportunity to benchmark best practice and adjust Union surveillance systems to changes in epidemiology, population behaviour and laboratory methods. Each dedicated network should therefore meet regularly and communicate between meetings, when necessary.

(4) The procedures for the operation of the network for epidemiological surveillance should be periodically evaluated to ensure that they respond to the Union needs for surveillance of communicable diseases.

(5) The measures provided for in this Regulation are in accordance with the opinion of the Committee on serious cross- border threats to health,

HAS ADOPTED THIS REGULATION:

Article 1 Procedure for membership in the dedicated networks on surveillance

1. On behalf of the national coordinating competent body of each Member State, as defined in Article 2(2) of Regulation

(EC) No 851/2004, the national coordinator shall designate members in the dedicated networks on surveillance (‘dedicated networks’). That membership shall be revoked if a network member moves into a new professional role outside the disease, related special health issue or public health function remit of the network.

(1) OJ L 314, 6.12.2022, p. 26, ELI: http://data.europa.eu/eli/reg/2022/2371/oj.

(2) Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/851/oj).

ELI: http://data.europa.eu/eli/reg_impl/2026/2096/oj 1/4EN OJ L, 21.9.2026

2. The designations provided for in paragraph 1 shall be:

(a) made electronically, through the dedicated stakeholder relationship management platform hosted by the ECDC;

(b) specific as to the specific role of the network member as a national focal point or operational contact point, and specific as to the dedicated network regarding disease, related special health issue or public health function.

3. The national coordinating competent body may also designate alternates to act as substitutes in the absence of the primary network members.

4. If no members are designated for a given dedicated network, all relevant surveillance interactions with the ECDC shall be channelled through the national coordinator.

Article 2 National focal points National focal points shall, each within their dedicated network:

(a) oversee any exchange of surveillance data or surveillance-related information between their Member State and the ECDC;

(b) advise their national coordinator on the designation of operational contact points and participants in network and other relevant meetings;

(c) provide scientific and technical advice to the ECDC;

(d) ensure submission of timely, complete and accurate national surveillance data and any other information relevant to surveillance to EpiPulse within the deadlines set by the ECDC after consulting the dedicated network;

(e) coordinate activities with other network members appointed by the same coordinating competent body and with relevant national actors as well as with relevant partners, including the EU Reference Laboratories for public health, and collaborate closely with their counterparts in the other Member States.

Article 3 Operational contact points Operational contact points shall, each within their dedicated network:

(a) be the main contact for any exchange of surveillance data or surveillance-related information between their Member State and the ECDC;

(b) submit timely, complete and accurate national surveillance data to EpiPulse within the deadlines set by the ECDC after consulting the dedicated networks;

(c) review draft surveillance outputs produced by the ECDC and contribute to the interpretation of surveillance results alongside the ECDC and the other operational contact points;

(d) inform the ECDC about national data sources and surveillance systems;

(e) oversee the implementation of surveillance metadata changes at national level;

(f) coordinate activities with other network members appointed by the same coordinating competent body and relevant national actors as well as with relevant partners, including the EU reference laboratories for public health, and collaborate closely with their counterparts in the other Member States.

2/4 ELI: http://data.europa.eu/eli/reg_impl/2026/2096/ojEN OJ L, 21.9.2026 Article 4 The ECDC secretariat

The ECDC shall:

(a) be the coordination and communication hub for all activities of the dedicated networks and provide the scientific secretariat and administrative support;

(b) provide:

(i) the dedicated stakeholder relationship management platform and relevant instructions for the designation of network members and updating of their membership status;

(ii) technical surveillance support and foster technical and scientific collaboration within and across the dedicated networks;

(c) organise regular network meetings to share data and best practices, highlight data quality issues and other surveillance shortcomings and discuss strategic choices within and across the dedicated networks;

(d) liaise with relevant partners, including the EU reference laboratories for public health, the World Health Organization (‘WHO’), other EU agencies, on behalf of the dedicated networks to coordinate activities (including on One Health), share data, facilitate cooperation or reduce Member State burden, as appropriate.

Article 5 Technical work procedures

1. The ECDC shall announce the start and end of each annual routine surveillance data collection to the dedicated networks and share with each of them the latest version of the relevant reporting protocol with the disease-specific common data structure.

2. The operational contact points of the dedicated networks shall submit their national surveillance data electronically to EpiPulse in compliance with the reporting deadline set by the ECDC after consulting the dedicated network and with the common data structure referred to in paragraph 1.

3. The operational contact points of the disease networks shall review the automated data validation report in EpiPulse and any additional validation feedback from the ECDC and, where applicable, resubmit data at the level of quality required to reach the surveillance objectives.

4. The ECDC shall analyse and communicate the routine surveillance data in a timely manner and at least at the frequency of data collection.

Article 6 Administrative procedures

1. The ECDC may appoint a coordination committee to facilitate communication between the ECDC and a given dedicated network.

2. The ECDC shall convene regular network meetings to discuss surveillance objectives, case definitions, metadata changes, data analysis plans, surveillance findings, best practices or technical innovations in consultation with the relevant network coordination committee, if appointed.

3. Network meetings may be held in person, online or in hybrid format, and the ECDC shall provide the secretariat.

4. The ECDC shall share a final agenda with the network no later than one week before the meeting. The ECDC shall take minutes and share a meeting report with all participants. It shall follow up on any matters requiring further action in consultation with the network coordination committee, if appointed, and report back to the network in writing or at the following network meeting.

ELI: http://data.europa.eu/eli/reg_impl/2026/2096/oj 3/4EN OJ L, 21.9.2026

5. When network meetings are held online or in hybrid format, the ECDC may invite written comments on proposals.

For any urgent technical discussion between network meetings, the ECDC may consult the relevant network coordination committee, if appointed, in writing or through online means.

6. The ECDC shall disseminate any documents for network or coordination committee meetings and consultations well in advance and leave sufficient time for thorough review and internal coordination of national positions and written opinions by the national coordinating competent body.

7. For surveillance schemes run jointly with the WHO, network meetings may be held jointly, with the ECDC and the WHO collaborating in organising these meetings and with cost arrangements to be agreed between the ECDC and the WHO.

Article 7 Periodic evaluation The ECDC and the dedicated networks shall periodically evaluate the procedures for the operation of the network for epidemiological surveillance and inform the Commission about the outcome of those evaluations.

Article 8 Entry into force 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, 18 September 2026.

For the Commission The President Ursula VON DER LEYEN 4/4 ELI: http://data.europa.eu/eli/reg_impl/2026/2096/oj