Article 61 never gives a proper guidelines with respect to what and how a Clinical Evaluation Report Conclusions should be!!
Clinical documentation as per MDR includes documents containing clinical data required to complete the clinical evaluation of a medical device are together referred to as clinical documentation. The following documents come under the clinical documentation:
- Clinical evaluation plan
- Clinical evaluation report and its updates
- PMCF plan
- PMCF evaluation report
CONTACT US FOR INSTANT GUIDANCE AND SUPPORT – FILL THE FORM
Can any one provide some insights into Clinical Evaluation Report Conclusion documentation as per the MDR Article 61
Clinical evaluation report is documentation of the conclusion of analyzed clinical data of medical device under evaluation, similar devices or equivalent devices from various scientific sources to prove the safety and performance of the device as per its intended use with purpose to get CE mark.
Clinical evaluation report concludes the conformity of the safety, performance, undesirable side effects and acceptability of risk-benefits ratio of the medical device as per its intended use under normal conditions with general safety and performance requirements (Annex I).
Demonstration of conformity with the relevant general safety and performance requirements shall be achieved by justification of clinical evidence from material supplied by manufacturers (IFU, preclinical investigation, PMS, PMCF) and from scientific literatures per the characteristics and intended purpose of device.
Currently available alternative treatments, demonstration of equivalence and state of the art shall also be considered while concluding the Clinical evaluation report followed by its updation throughout the lifetime of the device with any new information from PMCFs.