Clinical Evaluation Report Conclusions

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:

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