EPF's survey on the implementation of the EU Medical Devices Regulations

In November 2024, EPF published a report with the findings of a survey on the implementation challenges of the EU Medical Devices Regulation and the In Vitro Diagnostic Medical Devices Regulation.

The Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were adopted in 2017 to address serious shortcomings in the existing regulatory framework, including insufficient oversight leading to major safety issues, and inconsistent interpretations. MDR and IVDR introduced stricter quality standards, performance evaluations, and oversight across the device lifecycle, enhancing patient safety, transparency, and information. Although the MDR and IVDR promised significant improvements, full implementation is still pending and benefits to patients are yet to be fully fulfilled.

In order to have a full understading of the situation for patients since the adoption of the new framework, EPF conducted an online survey on the MDR/IVDR implementation for its member organisations and their networks between 25th July and 30th September 2024. The survey centred around three key aspects from a patient perspective: patient safety, availability/shortages and accessibility of medical devices, and information to patients.

This survey aimed to provide an initial overview of patients’ experience with medical devices and the regulatory framework.

Read the report "Patient Perspectives on Implementation Challenges of the EU Medical Devices Regulations: EPF Survey Findings" here.