A medical device is an instrument, apparatus, appliance, software, implant, reagent, material or other article intended for the use with human beings for medical purposes that are specified in more detail in Art. 2 EU MDR.
Manufacturers of medical devices must monitor their products on the market. The European Medical Device Regulation requires manufacturers to systematically and actively collect information on product use after it has been placed on the European market.
The European Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) and the Directive on Active Implantable Medical Devices (AIMDD). This article provides an overview of the major changes and the current status of implementation.
Medical devices that have an electrical power source must meet special safety requirements. The standard IEC 60601-1 describes these requirements and is therefore one of the most important and most extensive standards for medical devices.