lääkintälaiteasetus

Lääkintälaiteasetus refers to the regulatory framework governing medical devices in Finland. This legal framework implements the European Union's Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). These regulations ensure the safety and performance of medical devices placed on the market and put into service in the EU, including Finland.

The primary goal of the lääkintälaiteasetus is to protect public health and patient safety. It establishes a comprehensive set of requirements for medical device manufacturers, importers, distributors, and authorized representatives. These requirements cover the entire lifecycle of a medical device, from design and development to post-market surveillance.

Key aspects of the lääkintälaiteasetus include conformity assessment procedures, which determine whether a device meets the essential requirements before it can be placed on the market. It also mandates the establishment of a robust post-market surveillance system, requiring manufacturers to actively monitor the performance and safety of their devices once they are in use. Incidents and adverse events must be reported to competent authorities.

The Finnish Medicines Agency (Fimea) is the national competent authority responsible for the implementation and enforcement of the lääkintälaiteasetus in Finland. Fimea oversees market surveillance, approves notified bodies (organizations that assess conformity for certain high-risk devices), and provides guidance to stakeholders. The regulations are crucial for ensuring that medical devices used in Finland are safe, effective, and comply with high EU standards.