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  • QARA
    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
  • QARA
    Clinical Evaluation Report documentation expected from the date of CE Certification. This means PMCF and PMS start in the same period. Is the clinical evaluation updated throughout the life cycle of the device concerned with clinical data obtained
  • QARA
    Confused about Sufficient Clinical Data as per MDR Article 61. If the manufacturer can demonstrate the device is safe and achieves the intended benefits via data evaluation, it means the data is sufficient.   Clinical data is all
  • Clinical Evaluation
    Clinical Evaluation and Technical Documentation are interrelated in medical devices MDR compliance and both are the back born of the compliance process.   Clinical evaluation is a methodologically sound procedure to collect, appraise and analyze clinical data related
  • QARA
    Significance of Equivalent Device in new MDR 2017/745 Medical Device CE Marking   A CE marked device from another manufacturer can be considered to be equivalent to the medical device undergoing clinical evaluation, if the two devices are
  • QARA
    Clinical Investigation and Post Market Clinical Follow Up along with Post Market Surveillance should be planned, established, documented, implemented, maintained and updated for each medical device after it has been commercialized. It should be considered the device type
  • QARA
    Before obtaining CE Marking in the EU, medical device manufacturers must prove to the competent authority that their device meets safety and performance standards and hence, the EU MDR requires the clinical evaluation of their device. Clinical evaluation

1 thought on “Clinical Evaluation Report Conclusions

  1. 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.

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