Article 74 of the IVDR details the coordinated assessment procedure for performance studies. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit a single application for the purpose of Article 66. Upon receipt, this application is transmitted electronically to all Member States in which the performance study is to be conducted.
Until EUDAMED is fully functional, sponsors may express their willingness to join a pilot coordinated assessment of applications. A call for applications for a pilot coordinated assessment is currently open on the European Commission website. The pilot project will allow for a more harmonised involvement of sponsors and Member States in which the performance study will be carried out, and it will also reduce administrative burdens and ensure high levels of transparency and consistency in coordinated assessments.
Link to website: Pilot coordinated assessment for CI/PS – European Commission
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
