Are You Familiar With The Clinical Evaluation Consultation Procedure (CECP)?
The Clinical Evaluation Consultation Procedure (CECP) is an extra requirement of a clinical evaluation process under 745/2017 MDR for implantable Class III, and class IIb active devices intended to administer and/or remove a medicinal product. MDR intends to provide independent scientific opinions through expert panels that are formed with scientists that are considered experts in their field all around Europe.
The expert panel provides an opinion on the Clinical Evaluation Assessment Report (CEAR) prepared by the Notified Body based on the Clinical Evaluation Report (CER) of the manufacturer if the products in question are the same class as stated in MDR Article 54 (1). However, not every notification of a CEAR results in an opinion from the panel as there is a screening stage to decide if an opinion should be provided.
The opinions as well as the yearly statistics are made publicly available on the Official Public Health European Commission Website. The published opinions and the statistics are very crucial for all the manufacturers even though it’s not directly related to their own devices. The available data can be used to understand the point of view of an expert panel, to follow state-of-the-art of equivalent or similar devices, and to analyze shortcomings of other clinical evaluation reports. Furthermore, a recently published commission staff working document named Annual overview of devices subject to the clinical evaluation consultation procedure can be used to see which device groups are exempted from the CECP or which device groups were not provided an opinion. And this information can be used to further improve your device’s own clinical evaluation report.
List of opinions provided under the CECP: https://health.ec.europa.eu/medical-devices-expert-panels/experts/list-opinions-provided-under-cecp_en