Germany
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The German federal cabinet has passed the health ministry’s rejigged Healthy Heart Law draft, which features early diagnosis, restructured treatment planning and improved therapeutic care. Cardiologists and the diagnostics industry approve, but other parties have criticized the plan.
With the latest ruling in Germany, there is speculation that the Medical Device Regulation’s confusing Article 11 on software or the device’s timing of gaining its class I category may be to blame for the invidious position Dermanostic has found itself in.
Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.
How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.
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.
Europe’s largest national in vitro diagnostics market is evolving post-COVID, under the effects of new digital laws, artificial intelligence-enabled devices, apps on prescription and the rising popularity of continuous glucose monitors. The VDGH industry association’s latest survey indicates a changing market landscape for IVDs in 2024.
The enactment of pivotal laws governing the digitization of healthcare processes and the use of patient health data in Germany reached an important juncture upon sign-off by the lower house of parliament. The medtech industry bemoans the lack of an overall digital strategy and hears mixed messages on reimbursable healthcare apps.
Germany’s hospital reform will alter the local medtech market in ways yet to be fully appreciated. Furthermore, economic, supply chain and regulatory pressures have pushed the hands of Germany’s medtech Doomsday Clock closer to midnight. So says Marcus Kuhlmann, head of medtech division at the Spectaris industry association, in part 3 of Medtech Insight’s German industry updates from Medica 2023.
Higher logistics and energy costs are putting medtech P&Ls under pressure, and compliance with the EU MDR is draining any remaining surplus. Sustainability compliance is another cost to factor in, says BVMed chief executive Marc-Pierre Möll in part 2 of his interview with Medtech Insight at Medica 2023.
While revenues are looking healthier at last, a host of issues in the post-COVID readjustment phase still weigh heavily on medtech manufacturers in Germany, chief among which is EU and national over-regulation. Hospital reform and the digital shift are also on a long list of priority issues to monitor and tackle if Germany’s industrial base is to remain preeminent, said BVMed chief executive Marc-Pierre Möll.
Three central European industry associations have agreed to develop joint initiatives and form a collective voice with which to lobby decision-makers on medtech themes of mutual interest.
Medtech promotes more women to managerial roles than other industries, but senior leadership positions see a significant drop in women representation, indicating a "broken rung" higher up in the leadership ladder.
Large volumes of paper IFU accompanying medical devices are harming the environment, say German medtech organizations. Armed with national survey data, they want to raise the issue of expanding eIFU at European and national levels.
The major reform of Germany’s DRG payment system moved to the next stage after a federal-state working group delivered a key points document on 10 July. January 2024 remains the effective date for the system overhaul, which the government says meets health care budgetary and quality needs.
Germany enacted the EU’s Whistleblower Directive in national legislation on 2 July. Medtechs must ensure they comply with staged application deadlines, and time is running short.
The European Commission’s proposed AI Act entered high-level negotiations this month, generating a renewed interest among medtech stakeholders in this upcoming legislation and its impact on the sector.
The German government has introduced a draft law on governance and access to patients’ healthcare data, ahead of the EU’s implementation of the European Health Data Space regulation.
The proposed European Health Data Space aims to enable the seamless transition of health data sharing for certain purposes across the EU. A new report highlights how national variations in data storage and budgetary constraints may affect the initiative’s success.
Latest performance data for the German IVD industry show COVID-related revenues accounted for just 11% of diagnostics sales in the final quarter of 2022, leading the VDGH trade body to declare that the pandemic economy is at an end.