Medical Device Clinical Evaluation Study
In accordance with the Meddev 2.7.1 Rev 4 Guide, medical device producers should verify;
- The clinical benefit
- The clinical security
- The clinical performance
- The risks
of their products that they have produced with their clinical data, which will be obtained in compliance with the Meddev 2.7.1 Rev. 4 Guide.
If these expectations could not recompense with the applied “Clinical Evaluation” by providing sufficient clinical data, the producer must perform the “Clinical Evaluation” study which is much costlier and long-termed regarding the EN ISO 14155 Standard.
Clinical data does not only consist of the broadly known literature.
The guide assemblies the clinical data which can be used for clinical evaluation study in 2 groups as;
1. Data that are provided by the producer which are found in;
- PMS (Post Marketing Surveillance System) including the customer feedbacks
- Producer test reports
- Equal – similar product comparison
2. Data obtained from the literature.
Literature scanning should be done on reliable sources using proper key words. MEDLİNE which the Meddev Guide states (https://www.medline.com), PUBMED (https://www.ncbi.nlm.nih.gov/pubmed) and European Journals (https://www.elsevier.com) are helpful and reliable sources as a start.
The following words should be at least focused on while choosing the key word.
- Direct product and/or equal-similar product name or the brand name,
- Alternative product names,
- Product indications/complications/ side-effects
- Raw materials used in production and production technologies,
- Product security/ performance and tests accordingly…
Lastly the product supervisor, (T.R. Health Ministry and approved facilities have a preference of doctors) who is specified as the “technical supervisor” that has minimum 10 years of experience in the guide, should have a confirmation regarding the suitability of the completed clinical evaluation study and the obtained data in the final report of the clinical evaluation study.