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.Request information