In accordance with Regulation (EU) 2017/745, a medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for human beings for diagnostic, preventive, monitoring, treatment or alleviation purposes related to diseases, injuries or disabilities. Medical devices may also be used to investigate, replace or modify the anatomy or a physiological process. Their principal intended use is not achieved by pharmacological, immunological or metabolic means, although they may assist in such processes.
PRS S.A. is currently in the process of designation as a Notified Body under Regulation (EU) 2017/745 (MDR). This means the company is preparing to conduct independent conformity assessments of medical devices prior to their placement on the European Union market. The scope of activities will include, among others, manufacturer audits, review of technical documentation and issuance of certificates confirming compliance with legal requirements and quality standards.
