The EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), introduced in 2017, aims to enhance patient safety, transparency, and information through stricter quality standards, performance evaluations, and oversight across the device lifecycle. But not all changes have been fully put into action, and many patients are still waiting to see benefits.
To better understand the impact on patients since the adoption of these frameworks, the European Patient Forum (EPF) conducted an online survey between July 25 and September 30, 2024, targeting its member organizations and their networks. The survey focused on three key areas from a patient perspective:
- Patient safety
- Availability and shortages of medical devices
- Accessibility and information provided to patients
The survey sought to capture initial insights into how patients experience medical devices under the evolving regulatory framework.
Louise Bouman, Chair of the Dutch PH patient association, has taken part in the survey and has highlighted some of the key issues related to pulmonary hypertension care, including:
1. Delays in Device Approval: Regulatory delays can lead to the unavailability of essential medical devices. Such delays threaten patient safety and quality of life, emphasizing the need to streamline the approval process.
2. Performance Issues with Critical Devices: Devices like infusion pumps, crucial for administering life-saving PH medications, have shown significant performance issues. Malfunctions can result in life-threatening interruptions in treatment.
3. Lack of a Complaint Mechanism: The absence of a robust system for handling device-related complaints leaves patients without a clear process for addressing concerns.
4. EUDAMED Transparency and Engagement: The role of EUDAMED, the EU’s medical devices database, remains unclear. Questions about its promotion, target audience, and how patient organizations can support its implementation need urgent attention.
By addressing these gaps, the Medical Devices Regulation framework can better prioritize patient safety, ensure timely device availability, and involve patient organizations in improving transparency and oversight. These changes are critical for protecting the health and well-being of PH patients.
For the detailed European Patient Forum analysis, read the full report: “Patient Perspectives on Implementation Challenges of the EU Medical Devices Regulations: EPF Survey Findings” here.
