The European Commission and ERN stakeholders are continuing the revision of the methodology for the next five-year evaluation cycle of the European Reference Networks (ERNs). The updated framework aims to improve the efficiency, clarity, and proportionality of the evaluation process while reducing unnecessary administrative burden for participating healthcare providers and ERNs.
The revised methodology is currently under preparation and is expected to be finalised in Autumn 2026, with endorsement by the Boards of Member States (BoMS) anticipated during an extraordinary meeting (date to be confirmed).
Background
Regular ERN evaluations are an essential component of the ERN system established under the EU cross-border healthcare framework. The evaluations aim to:
- assess the quality of care delivered to patients with rare and complex diseases;
- evaluate how effectively ERNs fulfil their broader objectives;
- support continuous improvement of the ERN framework.
The first ERN evaluation cycle was launched in December 2022 and assessed 836 clinical centres across the ERN system. Following this experience, extensive feedback was collected from ERNs, healthcare providers, evaluators, and Member States to identify areas for improvement in future cycles.
Main objectives of the revised methodology
A key objective of the revision process is to simplify and clarify the evaluation structure.
During the first evaluation cycle, several measurable elements corresponding to institutional-level requirements had to be repeatedly assessed across multiple clinical centres belonging to the same institution. To address this, the revised methodology introduces a clearer distinction between:
- Healthcare Provider (HCP) institutions; and
- individual Clinical Centres.
This separation is expected to significantly reduce duplication of assessments and reporting requirements.
Who is involved in the evaluation process?
The evaluation framework involves multiple stakeholders, including:
- the European Commission;
- the Independent Evaluation Body (IEB);
- ERNs and participating healthcare providers;
- the Boards of Member States (BoMS).
As part of the upcoming preparations, BoMS representatives will also be asked to share with the European Commission the contact details of teams or units within ERN hospitals responsible for ERN evaluation and monitoring activities.
Next evaluation cycle
According to the current planning:
First phase — 2027
The next evaluation cycle is expected to start in the second half of 2027, following the Continuous Monitoring exercise of ERNs.
This first phase will focus on approximately 600 Clinical Centres that joined the ERN system in 2022.
Second phase — staggered approach from 2028 onwards
From 2028–2029 onwards (timeline to be confirmed), a staggered evaluation approach is expected to be introduced for previously evaluated members.
Under this model:
- only a subset of HCPs and ERNs will be evaluated at the same time;
- the first staggered phase is expected to involve approximately 300–400 Clinical Centres together with selected ERNs;
- the detailed methodology for selecting the Clinical Centres and ERNs included in each phase is still under development.
The revised approach is intended to distribute workload more evenly across evaluation cycles while maintaining robust quality oversight throughout the ERN system.