Clinical Evaluation

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.

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