According to the European Directives on medical devices and from 26 May 2020 according to the new Regulation 2017/745, medical device manufacturers must include a Clinical Evaluation of each product in the relevant technical file.
The evaluation must comply with specific performance and safety requirements.
The European Union has issued a specific guidance document on clinical evaluation (MEDDEV 2.7.1), and the New Regulation (2077/745) has introduced some additional requirements.
Merc will assist you with the Clinical Evaluation of your products by carrying out the following activities:
- 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 of MDR 2017/745.Request information