关键词：医疗设备;药物;评估;边缘产品;指令;欧洲;评价;立法;法规;治疗;药用产品
摘 要：The definition of a medical device, as reported by Council Directive 93/42/EEC and subsequent amendments and additions, and the definition of medicinal products covered by the amended Directive 2001/83/EC of the European Parliament and of the Council, highlight how these types of products can have a therapeutic effect on humans. It is possible to identify the applicable Community legislation taking into account the main mechanism of action by which the products ensure the activity that determines the therapeutic effect. In the case of a medicinal product the mechanism of action should be pharmacological, immunological or metabolic, while for a medical device the main mechanism of action should not be the same, but it may be assisted by the above mentioned mechanisms. Evaluation of some elements, which help to define what is meant by pharmacological, immunologic and metabolic mechanism of action, is a criterion of discernment for the correct regulatory position of products that have a therapeutic effect on humans.