Clinical evaluation according to the EU-Medical Devices Regulation (MDR) is a complex process that requires a thorough analysis and assessment of the available clinical data. Various aspects have to be taken into account. It involves the evaluation of the clinical performance and safety of the product based on clinical data and scientific evidence.
A comprehensive literature research shall be conducted to collect relevant clinical and preclinical data. Published studies shall be systematically searched and both positive and negative findings shall be considered. The collected data shall be analysed and evaluated to assess the clinical performance and safety of the product.
The results of the clinical evaluation are recorded in comprehensive documentation. This includes a summary of the clinical data, an assessment of the clinical performance and safety, and a conclusion on the conformity of the device with the requirements of the MDR.
In this context, BEO BERLIN helps companies to successfully perform the clinical evaluation according to MDR. BEO BERLIN has extensive expertise and experience in the field of medical advice and support.
It is important to note that the MDR clinical evaluation needs to be regularly updated to take into account new evidence and data. This ensures that the product remains compliant with current requirements and that safety and efficacy are guaranteed for patients.
Companies benefit from our expertise, experience and network in the medical device industry. BEO BERLIN enables an efficient and successful process of clinical evaluation according to MDR.