Medical Device Clinical Evaluation Study

Medical Device Manufacturers, in accordance with the MDCG 2020-5 and Meddev 2.7.1 Guidelines, shall assess the following for the medical devices they manufacture:

  • Clinical Benefit
  • Clinical Safety
  • Clinical Performance
  • Clinical Risks

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In accordance with MDCG 2020-5 and Meddev 2.7.1 Guidelines, clinical data obtained must be used to validate the following. If these expectations cannot be met through the “Clinical Evaluation” study by providing sufficient clinical data, the manufacturer is required to conduct a “Clinical Investigation,” which is a much more costly and time-consuming process, in accordance with the EN ISO 14155 Standard.

Clinical data is not limited to widely known literature. Clinical data that can be used in the guideline-based Clinical Evaluation study includes

 

  • Data from the PMS (Post Marketing Surveillance System), including customer feedback
  • Manufacturer’s Test Reports
  • Data obtained from comparisons with similar products
  • Data from literature sources
  • Data Provided by the Manufacturer, Including the Following:
  • These are categorized into two main groups.
  • Literature review should be conducted using appropriate keywords from reliable sources. Sources such as MEDLINE (https://www.medline.com), PUBMED (https://www.ncbi.nlm.nih.gov/pubmed), and European Journals (https://www.elsevier.com), as highlighted by the Meddev guidelines, are useful and reliable sources to start with.

When selecting keywords, the focus should be on at least the following terms.

  • The name or brand name of the product and/or similar products,
  • Names of comparable products,
  • Alternative product names,
  • Product indications/complications/side effects,
  • Raw materials used in production and manufacturing technologies,
  • Product safety/performance and related tests, etc.

Finally, in the final report of the clinical evaluation study, there must be approval from a product expert with at least 10 years of experience, as defined as a “Technical Expert” in the guidelines (it is preferred by the Ministry of Health of the Republic of Turkey and Notified Bodies that the expert be a physician), regarding the suitability of the clinical evaluation study conducted with the obtained data.