lækningabúnaði

Lækningabúnaður, also known as medical devices, refers to any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body, and which is not dependent upon being metabolized for the accomplishment of its primary intended purposes.

The regulatory landscape for medical devices is complex and varies by jurisdiction. In the European Union, medical devices are regulated by the Medical Device Regulation (MDR) which replaced the previous Medical Devices Directive (MDD). In the United States, the Food and Drug Administration (FDA) oversees medical devices. These regulations aim to ensure the safety and effectiveness of medical devices before they are placed on the market.

Medical devices encompass a vast range of products, from simple items like bandages and thermometers to complex technologies such as pacemakers, MRI scanners, and prosthetic limbs. They play a critical role in modern healthcare, enabling diagnosis, treatment, and rehabilitation for a multitude of medical conditions. The development of new medical devices is an ongoing process, driven by technological advancements and the evolving needs of patients and healthcare providers.