One day after the European medtech industry proposed short and medium term actions needed to support public health, patient safety, and the future sustainability of Europe’s health systems, concluding that “broad and comprehensive reforms” were needed, the EPSCO (Employment, Social Policy, Health and Consumer Affairs Council) meeting discussed similar measures proposed by several member states,…

The European Commission has published a Q&A on the obligation to inform about supply interruptions or discontinuations for specific devices, as required under the new Article 10a of the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR, 2017/746). This obligation, introduced by Regulation (EU) 2024/1860, affects manufacturers by mandating notification…

The European Parliament has adopted a resolution to update the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to avoid potential product shortages in the region, sketching out a timeline for when such changes will be proposed. The move comes as manufacturers have continued to voice concerns about the ability to meet deadlines…