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…
