At Eurosafe, we cover medical devices intended for dermal application.
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 in account the generally acknowledged state of the art."
For this purpose, Eurosafe reports its ability to conduct safety evaluation reports of class I medical devices. The scientific principles applied in these reports are inspired by the main principles used for cosmetics safety assessment.
The ISO 10993-1 standard describes procedure of biological evaluation, to be followed for all medical devices.
The biological evaluation report (also called BSER for Biological Safety Evaluation Report) must demonstrate that it has taken into account all data related to the medical device itself and its manufacturing process. The ultimate goal is to draw a firm conclusion regarding biocompatibility profile of medical devices.