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.