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.
The use of AI blurs the determination of classic software products because the training data alters the algorithm. Hence, all stakeholders are facing new challenges: the potentially continuing modifications as well as being very much depended on carefully selected training data. Therefore, currently AI algorithms need to be implemented in a frozen state in medical devices to receive clearance for US or EU market access.
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 quality management system is an essential component of a medical device manufacturer. The European Medical Device Regulation (MDR) has increased the importance of quality management even further.
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.
Medical device manufacturers must provide a technical documentation for their products. The technical documentation is a compilation of all relevant documents for a product.
Software like a medical app that has a medical purpose is legally a medical device. This article gives an overview of the path from a software to a medical device with CE-marking.
Manufacturers of medical devices must carry out a clinical evaluation of their products in order to be allowed to market them in Europe. To do this, the manufacturer must use clinical data to check whether the medical device is safe and efficient.
