MEdirektiivi
MEdirektiivi refers to the European Union's Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). These regulations replaced the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) as well as the In Vitro Diagnostic Medical Device Directive (IVDD). The MDR and IVDR aim to ensure a high level of safety and performance for medical devices and in vitro diagnostic devices placed on the EU market.
The regulations introduce stricter requirements for manufacturers, including enhanced pre-market scrutiny, post-market surveillance, and increased transparency.
The MDR applies to a broad range of medical devices, from bandages and crutches to sophisticated imaging