Medical devices and biocides
Eurosafe covers medical devices intended for dermal application, from the safety evaluation report to the biological evaluation report compliant with ISO 10993-1.
Regulatory toxicology
At Eurosafe, we cover medical devices intended for dermal application.
Safety assessment
According to the general safety requirements of Regulation (EU) 2017/745, medical devices shall be “safe […] and shall not compromise the clinical condition or the safety of patients, or the safety and health of users […] taking into account the generally acknowledged state of the art.”
For this purpose, Eurosafe conducts safety evaluation reports for class I medical devices. The scientific principles applied in these reports are inspired by the main principles used for cosmetics safety assessment.
Biological Safety Evaluation Report (BSER)
The ISO 10993-1 standard describes the biological evaluation procedure to be followed for all medical devices.
The biological evaluation report (also called BSER, Biological Safety Evaluation Report) must demonstrate that all data related to the medical device itself and its manufacturing process have been taken into account. The ultimate goal is to draw a firm conclusion regarding the biocompatibility profile of the medical device.