EC Announces Pilot of Coordinated Assessment of Clinical Investigations and Performance Evaluation

By Heather Crawford and Evangeline Loh

There had been lingering optimism about medical device manufacturers becoming able to use the coordinated assessment mechanism, but it wasn’t clear when this would happen. Now, the coordinated assessment procedure has been introduced in the Medical Devices Regulation (2017, 745, MDR, Article 78) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR, Article 74). The coordinated assessment procedure is a mechanism to permit a single application to multiple member states in which the Clinical Investigations and Performance Studies (CI/PS) would be conducted — a potential timesaver for medical device manufacturers.

Shorten medical device market access application process to multiple countries

While the European Commission (EC) document on the European database, EUDAMED (Gradual Roll-Out of EUDAMED, Q&A practical aspects, November 2024, Questions 18 and 19), left some optimism for the use of the coordinated assessment mechanism, it wasn’t clear when this would be considering the absence of the EUDAMED module on the CI/PS.

A coordinating member state would coordinate the assessment of the application, and the coordinating member state would share a draft assessment report for the other member states to review. Provided there were no objections, the conclusion of the coordinating member state would apply to all applicable member states.

Announcement of pilot

The EC posted a pilot “call for applications” (February 6, 2025) for coordinated assessments for CI/PS. The intent is to help develop the coordinated assessment procedure using applications submitted.  This would result in a “fast and fit-for-purpose EU system” once the EUDAMED CI/PS module becomes operational. 

Conditions of pilot

The CI and PS have to require authorization (MDR Article 62(1), IVDR Article 58(1)-(2), respectively). As to be expected, there have to be sites in at least two participating EU member states for CI/PS. The EC website provides a list of 19 participating EU member states plus Norway. The medical device must be a Class III or invasive Class IIa or Class IIb medical device. The IVD should be part of a performance study conducted according to Article 58(b), Article 58(c), or Article 58(2) for companion diagnostics (not using leftover samples).

Next steps

Medical device manufacturers and sponsors who intend to perform a clinical investigation (CI) in more than one EU member state identified on the EC website should complete the interest form and email it to SANTE-CA-CIPS@ec.europa.eu by June 30, 2025. A call for IVD submissions will be announced at a future date.  The EC will identify those selected for the pilot and submission of the application will be through CIRCA-BC.

Concluding remarks

At this time, the pilot is only open for medical devices, CI. This is a welcome step in testing the coordinated assessment procedure and reducing the burden on medical device manufacturers and sponsors interested in performing CI in the EU.