Team-NB members endorsed the paper, drawing on their shared experience of five years of the Clinical Evaluation Consultation Process (CECP) under Article 54 of the MDR. With discussions on the current revision of the MDR underway, the CECP remains a critical step in supporting the introduction and acceptance of novel, innovative high-risk medical devices in Europe. The paper also sets out recommendations from Team-NB members on how the process could be improved through collaboration with all key stakeholders.
