According to Regulation (EU) 2017/746, in vitro diagnostic (IVD) medical devices are instruments, reagents, kits, materials, software or systems intended by the manufacturer to be used for the examination of specimens derived from the human body—such as blood, tissue or other bodily fluids—solely or mainly to provide information concerning a physiological or pathological state, genetic predisposition or immune compatibility, as well as to monitor therapy. IVD medical devices do not act directly on the human body but serve as essential diagnostic tools in laboratory medicine.
PRS S.A. is currently in the process of designation as a Notified Body under Regulation (EU) 2017/746 (IVDR). This means the company is preparing to carry out independent conformity assessments of in vitro diagnostic medical devices before they are placed on the European Union market. These activities will include, among others, manufacturer audits, review of technical documentation and issuance of certificates confirming compliance with legal requirements and quality standards, ensuring the safety and reliability of diagnostic testing.
