The safety of the medical device is primarily assessed via an integrated risk management or a risk-based approach. With such an approach, the risks inherent to the use, design and manufacturing of a medical device are assessed, mitigated and controlled. As defined in the harmonized standard ISO 14971, risk management is one of the important tools for medical device safety. The regulation 2017/745 further defines some general safety requirements in its annex I. These requirements, the potential clinical investigation, the clinical evaluation and the risk management tools to control the risks show the safety of a medical device. All aspects discussed, justified, mitigated or controlled in these activities can add to the claim(s) made.