The European Commission has launched a public consultation seeking stakeholder input on the effectiveness of the EU Medical Devices Regulation (MDR, 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746) in a targeted evaluation. An announcement stated that the evaluation will help the Commission “take stock” and assess the effectiveness, efficiency, and proportionality…

Following the EPSCO meeting on 3 December 2024 at which the subject of MDR/IVDR reform was discussed, MedTech Europe has published its response to the out come of the meeting, available from here. In the statement, the industry association comments: “[W]e call for the swift adoption of immediate measures, and before the targeted evaluation’s conclusions….

In the light of the anticipated go-live of most of the European database on medical devices (EUDAMED) modules in 2025, MedTech Europe has summarised in a position paper its viewpoint on ensuring a smooth transition to its mandatory use, in which it calls for improved accessibility, efficiency and consistency through technical and regulatory measures in…

ECRI has issued it ‘Top Ten Health Technology Hazards Report’ for 2025, available from here. The report identifies potential sources of danger involving the use of medical devices and systems. Further, the report offers practical recommendations for reducing the identified risks, all with the goal of preventing harm. The List for 2025 is: 1. Risks…

The US Food and Drug Administration (FDA) has issued a much-anticipated final guidance document detailing how it plans to regulate changes to artificial intelligence (AI) enabled medical devices post authorization by using pre-determined change control plans (PCCPs), allowing manufacturers to update AI-enabled devices without filing an additional submission to the Agency. The document is titled…

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,…