Key data
| Regulation | Commission Implementing Regulation (EU) 2026/2097 of 18 September 2026 |
|---|---|
| CELEX Reference | 32026R2097 |
| Publication | 21 September 2026 |
| Entry into force | 18 September 2026 |
| Repealed regulation | Implementing Decision (EU) 2018/945 |
| Affected parties | Public health authorities, epidemiologists, public health laboratories and epidemiological surveillance systems |
| Category | European Regulation |
| Year | 2026 |
Health authorities throughout the EU have new notification obligations as of 18 September 2026. The Commission Implementing Regulation (EU) 2026/2097 establishes the updated list of communicable diseases and related health problems subject to epidemiological surveillance, and precisely defines the case criteria for each of them. In Spain, this implies a direct review of national epidemiological information systems to ensure compatibility with European standards.
The regulation expressly repeals the Implementing Decision (EU) 2018/945, which had been the reference framework for nearly eight years. The change is significant: updated case definitions are the technical instrument that determines what is notified, when and how, and any misalignment between the national system and the European standard creates gaps in coordinated surveillance.
What does this regulation establish?
Regulation 2026/2097 articulates two central elements:
- Updated list of communicable diseases and related health problems subject to epidemiological surveillance in the EU. This list is the official catalogue of pathologies on which Member States must collect and report data to the European network.
- Harmonized case definitions for each disease included in the list. These definitions establish the clinical, laboratory and epidemiological criteria that determine whether a case should be reported as confirmed, probable or possible.
The harmonization of case definitions is the technical core of the regulation. Without common criteria, data from different countries are not comparable and the coordinated response to cross-border outbreaks loses effectiveness. This need became especially evident during the COVID-19 pandemic, which acted as a catalyst to accelerate the update of the regulatory framework.
| Element | Decision 2018/945 (repealed) | Regulation 2026/2097 (in force) |
|---|---|---|
| Type of instrument | Implementing Decision | Implementing Regulation |
| Case definitions | 2018 criteria | Criteria updated to 2026 |
| Direct application in MS | Required transposition | Direct application without transposition |
| Reference context | Pre-COVID-19 pandemic | Post-pandemic, with integrated lessons |
A relevant aspect is the change in legal instrument: moving from a Decision to an Implementing Regulation strengthens the binding nature and direct application in all Member States without the need for additional national transposition.
Economic and operational impact
The impact of this regulation is not measured in direct fines to private companies, but in operational adaptation costs for public health system organizations:
- Review of epidemiological information systems: National and regional notification platforms will need to be updated to reflect the new case definitions. This may involve changes to forms, databases and validation workflows.
- Update of laboratory protocols: Public health laboratories will need to review their diagnostic confirmation criteria to align with the new European standards.
- Professional training: Epidemiologists, notifying physicians and public health technicians will need to understand the new definitions to apply them correctly in daily practice.
- Coordination with the ECDC: Spain must ensure that data sent to the European Centre for Disease Prevention and Control (ECDC) comply with the new formats and criteria.
The regulation strengthens the capacity for coordinated response to cross-border health threats, which in the long term reduces the economic and social cost of epidemics by enabling faster detection and containment.
Who does it affect?
- Public health authorities: Ministry of Health, regional health departments and national and regional epidemiological surveillance networks.
- Epidemiologists and public health professionals: Responsible for notification, analysis and communication of cases in the surveillance system.
- Public health laboratories: Centers that perform confirmatory diagnostics for diseases included in the mandatory surveillance list.
- Epidemiological information systems: Technological platforms and databases used for the collection and transmission of surveillance data.
- Hospitals and primary care centers: Insofar as they are the first link in the chain of case notification.
Practical example
A Spanish autonomous community detects an outbreak of a disease included in the new list of Regulation 2026/2097. The notifying physician applies the updated case criteria: if the patient meets the clinical and laboratory criteria defined in the regulation, the case is classified as confirmed and must be reported to the national network, which in turn communicates it to the ECDC.
If the regional epidemiological information system has not been updated with the new definitions, it may happen that a case that under the 2018 criteria was classified as probable is now confirmed —or vice versa—, generating data inconsistent with that of other Member States. This compromises the quality of European surveillance and may delay the detection of a cross-border outbreak, with the health and economic consequences that this entails.
Early adaptation of protocols avoids this type of misalignment and ensures that Spanish data are comparable and useful at the European level.
What should organizations do now?
- Review the updated list of diseases included in Regulation 2026/2097 and compare it with the previous list of Decision 2018/945 to identify new or eliminated diseases.
- Update case definitions in national and regional epidemiological information systems to reflect the new clinical, laboratory and epidemiological criteria.
- Review laboratory protocols for diagnostic confirmation to ensure alignment with updated European standards.
- Train notifying professionals (epidemiologists, physicians, public health technicians) in the new case definitions before classification errors accumulate in the records.
- Verify the compatibility of reporting systems with the formats required by the ECDC for data transmission at the European level.
- Document the changes made to protocols to be able to demonstrate compliance in audits or inspections by the competent authorities.
Frequently asked questions
What regulation does EU Regulation 2026/2097 replace?
Commission Implementing Regulation (EU) 2026/2097 expressly repeals Implementing Decision (EU) 2018/945, which had regulated epidemiological surveillance in the EU since 2018. All references to Decision 2018/945 in protocols and systems must be updated to the new regulation.
When did Regulation 2026/2097 enter into force and when was it published?
The regulation entered into force on 18 September 2026, the date of its adoption by the European Commission. Its publication in the Official Journal of the EU took place on 21 September 2026. As an Implementing Regulation, it is directly applicable in all Member States without the need for national transposition.
What are "case definitions" and why do they change?
Case definitions are the technical criteria (clinical, laboratory and epidemiological) that determine whether a patient should be reported as a confirmed, probable or possible case of a disease under surveillance. They are updated to incorporate diagnostic advances, lessons learned from the COVID-19 pandemic and the need to harmonize notification across the 27 EU Member States.
What should Spanish health authorities do to comply?
Spanish health authorities must review and adapt their epidemiological information systems to ensure compatibility with the new European standards. This includes updating case definitions in notification platforms, reviewing laboratory protocols and training notifying professionals in the new criteria.
Does this regulation affect private companies or only public bodies?
The regulation primarily affects public health authorities, epidemiologists, public health laboratories and epidemiological surveillance systems. Accredited private laboratories that participate in the surveillance network may also be affected if they perform confirmatory diagnostics for diseases included in the mandatory surveillance list.
Official source
Consult the complete regulation in the official source
Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=CELEX:32026R2097
