the Medical Device Regulation (MDR) is a European Union (EU) regulation on medical devices that came into force on 26 May 2021. It replaces the previous Medical Device Directive (MDD) and the Active Implantable Medical Devices Directive (AIMD).
Main features:
- Stricter controls for high-risk medical devicesStricter testing and monitoring procedures, especially for products with a higher risk potential.
- Increased transparency through an EU-wide database (EUDAMED): Introduction of a centralised Database for better traceability and transparency of medical devices.
- Introduction of unique device identification (UDI)Each medical device receives unique labelling for traceability and identification.
- Extended requirements for clinical assessments and evidence: Stricter requirements for clinical evaluation and documentation of safety and performance.
- Increased market surveillance after market launchMore intensive monitoring of products that are already on the market in order to recognise and rectify problems at an early stage.
The Medical Device Regulation (MDR) has a significant impact on the operation of Enterprise Resource Planning (ERP)-software in companies that manufacture, import or distribute medical devices or medical technology. ERP software is critical for managing business processes, and MDR compliance requires specific customisation and functionality within these systems.
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