ESC Leads Push for Stronger CE-Mark Evidence on High-Risk Devices
ESC Leads Push for Stronger CE-Mark Evidence on High-Risk Devices
Source: The Lancet , published online September 2025 – recommendations by ESC
Keynotes :
1-Background
• Europe’s CE Mark approval requires only safety and minimal efficacy, unlike the U.S. FDA which demands strong clinical proof.
• Cardiologists are urging tougher rules to protect patients and improve evidence quality.
2-ESC Initiative:
European Society of Cardiology (ESC), published new recommendations in The Lancet (September 2025).
3-Key Findings
• Many high-risk devices (cardiac, orthopedic, diabetic) entered the EU market without robust trials.
• The report calls for:
• Randomized controlled trials, including sham-controlled designs.
• Transparent data sharing and registry-based long-term follow-up.
• Clearer, science-based definitions of clinical evidence.
4-Expert Opinion
• Prof. Alan Fraser: The EU must move from legal interpretation to clinical science.
• Prof. Thomas Lüscher: Reliable, randomized evidence is essential for safety and innovation.
