lääkelaitevaatimukset

Lääkelaitevaatimukset refers to the regulatory requirements that medical devices must meet in order to be placed on the market. These requirements are established by competent authorities to ensure the safety and effectiveness of medical devices. The specific requirements can vary depending on the type of device and its intended use, but generally cover aspects such as design, manufacturing, risk management, clinical evaluation, labeling, and post-market surveillance.

In the European Union, the primary legal framework for medical device requirements is the Medical Device Regulation (MDR) (EU) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746. These regulations aim to create a more robust and transparent system for medical devices, strengthening safety and performance requirements. Manufacturers are responsible for demonstrating compliance with these regulations, often through a conformity assessment procedure.

Key elements of lääkelaitevaatimukset include the implementation of a quality management system (QMS), such as ISO 13485, to ensure consistent product quality and adherence to regulatory standards throughout the product lifecycle. Risk management, in accordance with standards like ISO 14971, is crucial to identify, evaluate, and mitigate potential risks associated with the device. Furthermore, manufacturers must conduct a clinical evaluation to demonstrate the safety and performance of the device for its intended purpose. This often involves collecting and analyzing clinical data.

Compliance with lääkelaitevaatimukset is essential for manufacturers to obtain a CE mark, which signifies that the device meets the essential requirements and can be legally marketed within the European Economic Area. Post-market surveillance activities are also a critical component, requiring manufacturers to monitor the performance and safety of their devices once they are in use and to report any adverse events.