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 range of products from simple bandages to complex implantable devices. Key objectives of the MDR include ensuring patient safety, providing clearer information to users and healthcare professionals, and harmonizing the requirements across EU member states.

Under the MDR, manufacturers must adhere to stricter rules regarding clinical evaluation, post-market surveillance, and traceability of devices. It also introduces new classifications for certain devices and requires conformity assessment procedures to be carried out by Notified Bodies. The Finnish Medicines Agency (Fimea) is the competent authority responsible for overseeing the implementation and enforcement of the MDR in Finland. Compliance with the MDR is essential for manufacturers and importers wishing to make their medical devices available in the Finnish and broader European market.