Medical Devices: Clinical investigations and performance studies - Pilot coordinated assessment

Clinical investigations and performance studies are critical in ensuring the safety and performance of medical devices and in vitro diagnostic, medical devices.

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.

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, improving and 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:

1. 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.
2. The study must be multinational and involve at least two participating Member States agreeing to join the coordinated assessment pilot.
3. 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 out under Article 58(b)
     • performance studies carried out under Article 58(c)
     • performance studies carried out under Article 58(2) involving companion diagnostics.

Participating Member States

The following Member States expressed interest in participating in the pilot coordinated assessment: Austria, Belgium, Czech Republic, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden and Norway.

The current availability along with practical details for each Member State. 

Submission of an application

Sponsors interested in participating in the EU pilot coordinated assessment should:

For medical devices.

• complete the expression of interest form
• email it to: SANTE-CA-CIPS@ec.europa.eu by the 30th of June 2025.

Use “Expression of interest for coordinated assessment pilot” as the subject line of your email.

The call for IVD will be opened at a later stage.

Selection

The expressions of interest will be reviewed on a rolling basis by MDCG Clinical Investigation and Evaluation Working Group members based on:

• eligibility criteria
• potential impact of the proposed clinical investigation
• performance study on public health.

Selected sponsors will be notified immediately after the review is finalised, and additional instructions will be provided (see FAQ).

Once a sponsor is selected for the pilot, the secretariat will provide an information package outlining the next steps.

The sponsor will have two weeks to raise questions and request bilateral exchanges with the secretariat and Member States for clarification if needed.

Pilot coordinated assessment for CI/PS

Medical Devices - Clinical investigations and performance studies

National requirements for clinical studies

Guidance documents endorsed by the Medical Device Coordination Group to assist stakeholders with the implementation of the medical device Regulations, including Regulation (EU) 2017/746.