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. They also aim to harmonize the regulatory framework across EU member states, facilitating smoother market access for compliant devices. Key aspects include improved traceability through unique device identification (UDI), mandatory clinical evaluation and evidence, and more robust post-market surveillance systems.

The MDR applies to a broad range of medical devices, from bandages and crutches to sophisticated imaging equipment and implants. The IVDR specifically covers devices used to diagnose diseases, conditions, or infections from samples taken from the human body. The transition to these new regulations has been a significant undertaking for the medical device industry, requiring substantial investment in compliance and process changes. The overarching goal is to protect patient health and safety while fostering innovation in the medical technology sector.