The BioMed Alliance has released a policy document which includes recommendations of healthcare professionals to address persisting challenges in the implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR). 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
- No support to ensure in-house tests can continue their vital role in the health system
- No special provisions are in place to safeguard the continued availability of legacy IVD tests
- Barriers to innovation
- Increasing regulatory complexity
- Fragmented governance
- Insufficient recognition of established laboratory quality control procedures
- Need to strengthen stakeholder involvement
