Clinical Evaluation


Clinical Evaluation

According to the European Directives on medical devices, medical device manufacturers must include a Clinical Evaluation of each product in the relevant technical file.

The evaluation must respond to specific performance and safety requirements.

The European Union has issued a specific guidance document on clinical evaluation (MEDDEV 2.7.1), and the New Directive on Medical Devices (2007/47) has introduced some additional requirements. Merc will assist you with the Clinical Evaluation of your products by carrying out  the following activities:

  • Analysis of the need for a Clinical evaluation
  • Clinical data assessment (collection of scientific literature, search for clinical data on similar devices)
  • Safety and performance evaluation (risk assessment)
  • Review of scientific literature
  • Final report

Merc is able to provide you with support in preparing the Clinical Evaluation of the product according to the new requirements.

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Clinical Evaluation