Today, the BioMed Alliance, together with the European Patients Forum (EPF), the European Association of Hospital Pharmacists (EAHP), and the European Hospital and Healthcare Federation (HOPE), published a joint open letter urging the European Commission to address critical shortcomings in its revision of EU Medical Devices Regulation (MDR). While we welcome the intended purpose of the Regulation to enhance safety of devices in Europe, there are certain issues that must be addressed including a lack of pathways for orphan and breakthrough devices, limited transparency, and limited coordination and oversight.
In a letter addressed to President Ursula von der Leyen and Commissioner Olivér Várhelyi, the four organisations representing medical societies, patients, hospital pharmacists and hospitals outline three urgent priorities for the targeted revision of the MDR. These build on previous recommendations of the respective organisations and reflect a shared commitment to improving the EU regulatory landscape for medical devices:
- Clarify clinical evidence requirements and make clinical evidence public
- Improve consistency and create a central body for scientific co-ordination
- Improve coordination to address safety issues
A targeted reform is necessary to ensure the system is science-driven, transparent, and responds to patients’ and healthcare professionals’ needs.
