EC announces a Call for Coordinated assessment for clinical investigations

Benefits

By participating in the pilot for coordinated assessment, sponsors can benefit from the following:

• Unified engagement: engage with all the EU countries involved, thus making communication more efficient and clearer while reducing delays.
• More transparency and harmonisation: the pilot will enhance transparency, giving sponsors better visibility of the evaluation process across EU countries by access to the operational procedures. Member States will work together becoming familiar with each other’s practices and particularities, thus increasing harmonisation.
• Simplified requests for information: experience a more efficient request for information (RFI) process, reducing potential complexities compared to non-coordinated assessments.
• Consistency across Member States: reduce discrepancies in assessment due to different national interpretations.
• Document management efficiency: a lower number of submissions is expected during the assessment process.
• Simplified management of substantial modifications: substantial modifications are also planned to be coordinated, ensuring a smooth and coherent process.
• Faster overall process: coordinated assessment procedures will enable faster decisions at the national level.

Who can apply and eligibility conditions

Sponsors conducting clinical studies that involve multiple Member States are encouraged to apply. However, to participate in the pilot, sponsors must meet the following criteria:

• The clinical investigation or performance study must require authorisation under Article 62(1) of the Regulation (EU) 2017/745 (MDR) or Article 58(1)-(2) of the Regulation (EU) 2017/746 (IVDR), as detailed below.
• The study must be multinational and involve at least two participating Member States agreeing to join the coordinated assessment pilot.
• For the medical devices, the investigational device must fall into one of the following categories:

• • • Medical Devices Regulation (MDR): investigational devices in class III
      – invasive investigational devices in class IIa
      – invasive investigational devices in class IIb
    • In Vitro Medical Devices Regulation (IVDR): performance studies carried under Article 58(1)(a)
      – performance studies carried under Article 58(1)(b) or (c)
      – performance studies carried under Article 58(2) involving companion diagnostics.