The Dutch Government has released crucial guidance for medical device manufacturers to align their processes with MDR requirements. Here’s a summary of key focus areas:
- Register in EUDAMED – Ensure all devices are registered in the European Database on Medical Devices for traceability and streamlined safety tracking across the EU.
- Risk Class Adjustment – Reassess device classifications, as MDR may shift products into higher risk categories, affecting certification timelines and requiring more stringent data.
- Conformity Assessment – Verify if your device requires a conformity assessment by a Notified Body to bear the CE mark, particularly if it’s classified as higher risk.
- Enhanced Clinical Evidence – Prepare comprehensive clinical evidence to meet MDR’s updated requirements, particularly for high-risk devices, including additional studies if needed.
- Performance and Safety Customization – Customize your assessments to meet the General Safety and Performance Requirements (GSPR), covering all performance and safety aspects relevant to your device.
- Person Responsible for Regulatory Compliance – Designate a qualified individual responsible for overseeing MDR compliance, ensuring your organization maintains high standards of regulatory adherence.
- Post-Market Surveillance (PMS) Plan – Implement an active PMS plan focused on real-world data collection and monitoring, enabling early detection of issues and facilitating device improvements.
- Unique Device Identification (UDI) – Apply a UDI code to all devices to enhance traceability, simplify recalls, and improve access to safety information.
Each of these steps is essential for comprehensive MDR compliance and ultimately contributes to safer, more effective medical devices. If you need support implementing these changes, Starodub can be your trusted partner. Check our Gap Analysis for MDR 2017/745 service description or contact us to learn more!
