CCMO participates in pilot coordinated assessment
CCMO is participating in the EU pilot for coordinated assessment. Until EUDAMED becomes available medical devices under the MDR (and the IVDR) are being assessed on a multinational basis as part of a trial.
The Netherlands is participating as Member State Concerned, with the CCMO coordinating this process between the different Member States. The first study has already been submitted, the MREC Erasmus MC will act as the reviewing committee. During the pilot, other MRECs will also be involved in the process. More information is available at: Pilot coordinated assessment for CI/PS - European Commission