The BioMed Alliance has released two policy documents which include recommendations of healthcare professionals to address persisting challenges in the implementation of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR). While these regulations aim to enhance the safety and transparency of medical devices and diagnostics across Europe, there are certain shortcomings that must be addressed in the evaluation process that is currently ongoing.
Clinicians have raised key concerns, including delays in implementation, the limited capacity of Notified Bodies, high certification costs, delayed roll-out of EUDAMED and reduced patient access to essential devices—particularly for paediatric and orphan devices. Furthermore, increased requirements for diagnostic laboratories under IVDR threaten the availability of essential diagnostics.
To address these pressing issues, the BioMed Alliance calls for urgent action to establish a patient-centred regulatory framework that is transparent, consistent, evidence-based, risk-proportionate, flexible, efficient, and interactive.
BioMed Alliance’s policy recommendations emphasise the need for a new coordinating mechanism to tackle critical systemic challenges, such as:
- Excessive certification costs
- Insufficient clinical evidence and lack of transparency
- Limited access to orphan and paediatric devices
- Increasing risk of devices being withdrawn from the EU market
- Barriers to innovation
- Increasing regulatory complexity
- Fragmented governance
