In Vitro Diagnostics

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• Increasing risk of devices being withdrawn from the EU market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

 

We are pleased to welcome the European Commission decision to include the Q&A on Article 10a, "The Information Obligation in Case of Interruption or Discontinuation of Supply of Certain Medical Devices and In Vitro Diagnostic Medical Devices," within the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). This new mechanism aims to create a much-needed framework for managing shortages and ensuring continuity in the availability of critical medical devices across Europe. The Q&A provides guidance on the practical aspects on the obligation to inform about interruption or discontinuation of supply. As a results of our advocacy activities to protect patients’ access to life-saving devices and diagnostics, earlier this year, we issued a statement highlighting our deep concerns over issues with the availability of In Vitro Diagnostic Devices (IVDs) in Europe. The BioMed Alliance warned of widespread challenges due to delayed IVDR implementation, the limited number of certificates being issued, ongoing delays in the EUDAMED database, and general industry unpreparedness. These issues have raised the serious risk of losing essential IVDs from the market, which could compromise patient care and Europe’s competitive standing in the global medical device sector. To counter these challenges, our January statement called for a mix of short- and long-term reforms, including an urgent extension of the IVDR transition period and targeted updates to the system's framework. The new Q&A guidance of Article 10a provision now provides a structured response to manage supply interruptions, ensuring that information flows effectively between manufacturers, regulators, and healthcare providers. Article 10a not only reinforces patient access to essential devices but also strengthens Europe’s position in the global medical technology market. We remain committed to further actions that ensure the sustainability and efficacy of Europe’s medical device sector for the future.