A parliamentary question from the center-right CDU/CSU party (Union) in Germany’s lower house (Bundestag) on the high cost and needlessly burdensome compliance requirements the Medical Device Regulation (2017/745) prompted an instructive Q+A during a hearing on the state of the EU regulatory system.
EU MDR Failings Aired At German Parliamentary Hearing
Liese’s Proposal For EU Medtech System Adds Timely Context To Debate
MPs from across Germany’s political spectrum grilled a panel of national medtech stakeholders on the problems of the MDR and the EU regulatory system during an hour-long sitting of the Bundestag’s health committee on 5 June.
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The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.
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Whoever is handed the health portfolio in Germany’s new coalition government will face demands to amend the recently-enacted hospital and DRGs reform law. The medtech industry has been quick to make the case for change.
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Germany’s Union parties may have little alternative than to bring the SPD into a new four-year coalition, says Clifford Chance partner and life sciences legal expert Gunnar Sachs. Health policy will likely see both textural and structural changes.
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Germany’s government-industry healthcare industry roundtables have yielded a final report, even though the program was curtailed by the snap election. The new CDU-led government should pick up the baton, medtech industry associations say.
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The urine-based GAGome test showed promise in the first clinical results from the international AURORAX-0087A, in the largest study conducted on clear cell renal cell carcinoma, the most common type of kidney cancer.
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With the support of AIM-MASH AI Assist only one pathologist is needed to reliably make a histology assessment of inflammatory liver disease to decide whether patients should be included in MASH clinical trials.
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Barcelona-based accelerator S2 Xpeed is driving the rapid growth of medtech and hardware start-ups in Europe. Operating under a "sweat equity" model, the program helps early-stage companies move from prototype to manufacturing readiness in exchange for equity. This month, the accelerator will add a fourth cohort of 10 more start-ups, five of which are in the medtech space.