Pilot coordinated assessment for CI/PS: a new step towards European coordinated assessment of clinical studies
News
The European Union has just launched a pilot for thecoordinated assessment of Clinical Investigations (CI) and Performance Studies (PS) under Articles 78 of Regulation (EU) 2017/745 (MDR) and 74 of Regulation (EU) 2017/746 (IVDR).
This initiative aims to harmonize the regulatory assessment of multicenter studies conducted in several member states.
Why this pilot?
Until now, each national authority assessed the same study separately, generating discrepancies in timing and interpretation.
The pilot coordinated assessment aims to test a unified approach: a single submission, coordinated assessment between Member States, consolidated feedback to the sponsor.
This model anticipates the future coordinated assessment system set out in the MDR and IVDR regulations, which are still in the implementation phase.
Who can participate?
The pilot is open to sponsors wishing to submit a study:
for an Article 62(1)medical device (MDR):
class III device, or
invasive class IIa/IIb device;
for an in vitro diagnostic device (IVDR) covered by article 58:
performance study under 58(1)(b), 58(1)(c) or 58(2).
The study must involve at least two member states participating in the pilot (from among : France, Germany, Italy, Spain, Belgium, Netherlands, Ireland, Sweden, etc.).
What are the benefits for the sponsor?
Participating in the pilot offers several concrete advantages:
A single submission for several member states;
Single communication with one coordinator;
Fewer regulatory discrepancies, thanks to a common assessment report;
More consistent treatment of substantial modifications;
Better visibility on the future logic of the coordinated European system.
For manufacturers planning multi-center studies in the EU, this represents a significant simplification of the authorization process.
How to apply?
Interested sponsors should submit an expression of interest form ("Expression of interest for coordinated assessment pilot") by April 30, 2026, to :
SANTE-CA-CIPS@ec.europa.eu
Applications are evaluated on a rolling basis by the MDCG Clinical Investigation and Evaluation group, according to :
regulatory eligibility of the device,
european scope of the study,
and public health interest.
Once selected, the sponsor receives an information package specifying the applicable procedures, models and operating modes.
Points to watch
The pilot is voluntary, but represents a strategic preparation for the future generalization of the coordinated evaluation system.
Each national authority retains responsibility for its own ethical and linguistic aspects.
Documents (Clinical Investigation Plan, Investigator's Brochure, etc.) must follow the MDCG 2024-3 and 2024-5 formats.
Coordination of amendments is part of the system: the sponsor must anticipate the centralized management of amendments.
The number of studies accepted remains limited; early planning is recommended.
Two typical cases
Case 1 - Multicenter MDR study on a class III implant
A manufacturer wishing to include 4 European countries can file a single dossier under the pilot, receive a coordinated report and limit parallel exchanges with the authorities.
Case 2 - IVDR study on a companion diagnostic
An IVD developer targeting several member states benefits from a centralized assessment of performance documentation and ethical aspects, while respecting local specificities.
What this means for manufacturers
Strategic planning: identify participating member states, align documents and translations.
Regulatory coordination: centralize exchanges and ensure consistency between study sites.
Documentary anticipation: adopt harmonized MDCG models now, as they will soon be mandatory.
Active regulatory watch: feedback from the pilot will guide future mandatory implementation of coordinated assessment.
Related resources
In practice
This pilot marks an important step towards a unified European approach to clinical and performance evaluation.
Manufacturers and sponsors who commit to it now will take a strategic lead: their processes and dossiers will already be aligned with the future European model.
CSDmed supports its customers in the preparation, structuring and coordination of their clinical investigation and multicenter performance study dossiers, to maximize their chances of acceptance within this new framework. Let's talk about it.