MDRdirektiivien
MDRdirektiivien refers to the Medical Device Regulation (MDR) in Finland, which implements the European Union's Medical Device Regulation (EU) 2017/745. This regulation replaced the previous Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) to enhance the safety and performance of medical devices placed on the European market.
The MDR establishes a more robust and transparent regulatory framework for medical devices, covering a wide
Under the MDR, manufacturers must adhere to stricter rules regarding clinical evaluation, post-market surveillance, and traceability