- Clinical evaluation assessment report template released by the MDCG
Clinical evaluation assessment report (CEAR) will document the conclusions of the Notified Body assessment of the manufacturer’s clinical evidence and the related clinical evaluation that was conducted, which includes as per the MDCG:
- Assessing the suitability of using data from claimed equivalent devices, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.
- Verifying that the clinical evidence and the clinical evaluation are adequate and shall verify the conclusions drawn by the manufacturer on the conformity with the relevant general safety and performance requirements. That verification shall include consideration of the adequacy of the benefit-risk determination, the risk management, the instructions for use, the user training and the manufacturer’s post-market surveillance plan, and include a review of the need for, and the adequacy of, the PMCF plan proposed, where applicable.
- Considering the clinical evaluation and the benefit-risk determination, and whether specific milestones need to be defined to allow the notified body to review updates to the clinical evidence that result from post-market surveillance and PMCF data.
Apart from providing a harmonised CEAR template (which represents the minimum content for a CEAR and needs to be incorporated into the process and procedures of the Notified Body) and related instructions, the MDCG also recalls the importance of clinical evaluation under the MDR for the manufacturer. The MDCG stresses that it must be a part of the manufacturer’s quality management. It should also be aligned with and reflected in other aspects of the technical documentation, such as:
- The interface of the clinical evaluation with the risk management process and its appraisal and analysis of the pre-clinical and clinical evaluation and their relevance for the demonstration of conformity with the relevant requirements in Annex I.
- Post-market surveillance including any corrective and preventive actions involving the device.
- Post-market clinical follow-up plan and where appropriate the post-market clinical follow-up report.
- Instructions for use, which provide adequate information on intended purpose, proper use and warnings about risks to patients and healthcare practitioners.
Also published this week:
- Minutes from MDCG sub-groups on Standards and IVD are now public;
- Update to Notified Body designation process;
More in our Library of Documents!