Call for applications
Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States as per Articles 78 of the Regulation (EU) 2017/745 (MDR) and 74 of the Regulation (EU) 2017/746 (IVDR) respectively.
This pilot will allow sponsors to submit a single application for pilot coordinated assessments, assuring more harmonised interaction with the Member States approving the clinical investigation or performance studies.
Additionally, participant sponsors will help the competent authorities of Member States with building a fast and fit for purpose EU system for coordinated assessment once its mandatory operation starts as required in Article 78 (14) MDR and Article 74 (14) IVDR (modified by Regulation (EU) 2024/1860, Articles 1(3) and 2(2) respectively).
The goal is to implement a harmonised, predictable process across Member States, reducing administrative burden for sponsors and ensuring high transparency and consistency in the coordinated assessment.
Pilot coordinated assessment for CI/PS - European Commission
Pilot coordinated assessment for CI/PS
Member States, supported by the European Commission, are pleased to announce the launch of a pilot coordinated assessment of clinical investigations and performance studies across multiple Member States.
health.ec.europa.eu