Table of Contents
Medical Device Registration in Ukraine: Requirement list
EU Certificate of conformity
Essential requirements
Label
Instruction for use
(for III class) Design examination certificate
EU Declaration of conformity
2. Technical file (STED) with information
General description of medical device
Risk analysis
Sterilization report (if product is supplied in sterile state)
Validation of sterilization (if product is supplied in sterile state)
Validation of measuring function (is product is with measuring function)
Software validation (if any)
Pre-clinical evaluation (biocompatibility, toxicity etc)
Clinical evaluation
EMC testing
(For III class) content of medical devices, formula
(For III class) report on medicines effectiveness
Shelf-life report
Quality manual of legal manufacturer
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