The definition of medical devices is as vast and varied as the range of applications they cater to. With the exception of certain products, such as pharmaceuticals, a wide array of products contributing to human health are encompassed within the European Regulation (EU) 2017/745 (Medical Devices Regulation).
Medical devices, unlike most product groups, are categorized based on risk classes, distinguishing between low, medium, or high-risk products. The requirements encountered by economic actors vary depending on the product's type and risk class. The initial challenge lies in accurately classifying the product, a task demanding the extensive expertise and experience of a specialist.
For medical devices, proof of CE conformity is mandatory. This product group has specific requisites not applicable to others covered by the 'CE obligation.' Notably, these include the necessity for a quality management system, preclinical and clinical evaluations, a vigilance system, and monitoring of post-market phases.
Furthermore, manufacturers need a designated responsible person possessing formal qualifications and at least one year of professional experience in related regulatory matters or quality management systems. Alternatively, four years of the mentioned professional experience suffice. Small and medium-sized enterprises also have the option to appoint an external expert to fulfil this role.
