European Commission announces pilot for coordinated assessment of clinical investigations
EU Member States have launched a pilot program to accept single applications for the assessment of clinical investigations and performance studies, coordinated by the European Commission and in line with the Medical Device Regulations (MDR) and In Vitro Diagnostic Device Regulations (IVDR).Under the pilot program, sponsors can submit a single Clinical Investigation and Performance Studies (CI/PS) application for review across multiple Member States, rather than submitting separate applications to each Member State.
Article 78 of the MDR and Article 74 of the IVDR call for coordinated assessment procedures for clinical investigations and performance studies.
According to a European Commission announcement, participating in this initiative will help Member States create a coordinated assessment system that is "fast and fit for purpose" before it becomes mandatory. Sponsors will benefit from more streamlined interactions with the Member States responsible for approving clinical investigations or performance studies.
The MDR specifies that participation in these assessments is voluntary until 27 May 2027. The IVDR states that participation will be mandatory two years later, on 27 May 2029.
To participate, products must be authorized under MDR or IVDR, and the study must involve at least two participating member states that have agreed to take part in the pilot. The pilot includes investigational medical devices in Class II and invasive investigational medical devices in Class IIa or Class IIb.
IVDs must require performance studies carried out under Article 58(b) or Article 58(c), or require performance studies carried out under Article 58(2) involving companion diagnostics.
According to a question-and-answer document released with the announcement, pilot program results will be shared with participating Member States. Non-participating Member States may access the findings if the sponsors grant permission.
The Q&A clarifies that while ethics committee approval is not necessary before submitting applications for the pilot, some Member States may require it before applications can be submitted at the national level.
Twenty member states, including Austria, Belgium, the Czech Republic, Estonia, Finland, France, Germany, Greece, Ireland, Italy, Latvia, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovenia, Spain, Sweden, and Norway, are participating in the pilot.
The Medical Device Coordination Group’s (MDCG) Clinical Investigations Evaluation Working Group will review the applications on a rolling basis.
Interested medical device sponsors send a completed expression of interest form to [email protected] by 30 June 2025. The calls for IVD participation will be announced at a later date.
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