‘Conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled (Art. 2 (40) EU MDR)
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- NB's New Requirements for AI-based SoftwareNotified Bodies have published a question catalog for medical devices with AI-based software. To meet the requirements, manufacturers should complement their processes.
- Quality management for medical devices: ISO 13485The 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.
- The EU Medical Device Regulation (MDR): What is changing?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.
- Technical Documentation of Medical Devices According to MDRMedical device manufacturers must provide a technical documentation for their products. The technical documentation is a compilation of all relevant documents for a product.
- Medical apps or software: classification and approval as medical deviceSoftware 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.