In February 2025, the European Commission and Member States have launched a pilot program for coordinated assessments of clinical investigations and performance studies under EU regulations (MDR & IVDR). This project allows sponsors to submit a single application for approvals across multiple Member States, promoting harmonisation and reducing administrative burdens. The pilot will also help authorities develop an efficient EU-wide system for coordinated assessments in the future, ensuring transparency and consistency.
How it works and who can apply
By joining the coordinated assessment pilot, sponsors can benefit from unified engagement with EU countries, improved transparency, and greater harmonisation. The process simplifies information requests, ensures consistency across Member States, reduces submission volumes, simplify substantial modifications’ management, and speeds up decisions at national level.
Sponsors of clinical studies that involve multiple Member States are encouraged to apply. The countries participating to the pilot are: Austria, Belgium, Czech Republic, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden, and Norway.
The criteria for eligibility are:
- For medical devices (MDR): clinical investigation must require authorisation under Article 62(1), meaning that the clinical study is carried our to verify that the investigational device meets its intended purpose under normal conditions, provides the claimed clinical benefits, and ensures clinical safety, assessing any side effects and weighing risks against benefits. In addition, the device has to be an investigational device in class III, an invasive investigational devices in class IIa, or an invasive investigational devices in class IIb.
- For IVD medical devices (IVDR): performance study must require authorisation under Article 58 (1)(2), meaning that the performance study is either a companion diagnostic study, or involves interventional procedures, or additional invasive procedures or other risks.
Submission of application and selection
For medical devices, sponsors interested in participating should complete the expression of interest form and email it to SANTE-CA-CIPS@ec.europa.eu (with “Expression of interest for coordinated assessment pilot” as email subject). Deadline for submission is 30 June 2025. The call for IVD will be opened at a later stage.
The MDCG Clinical Investigation and Evaluation Working Group members will review the applications on a rolling basis. Afterwards, the sponsors selected will be notified and the secretariat will provide more information. Eventually, the sponsor will have two weeks to raise questions and request bilateral exchanges if necessary.
Non-EU sponsors of clinical studies
If you are a sponsor of a clinical investigation or performance study and are not based in the Union territory, you have to ensure that a natural or legal person is established in the Union as your legal representative.
Contact us here or at mdlaw@obelis.net for more information.
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