Germany
A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.
Germany’s incoming coalition government has reacted positively to industry’s calls for a dedicated medtech strategy to boost economic growth. Faster digitization, lower energy costs and “IVDR 2.0” are also on the in vitro diagnostic industry’s agenda.
The architect of Germany’s hospital reform, Karl Lauterbach, will not be retained as health minister according to how the new CDU/CSU-SPD coalition government plans to spread the ministerial portfolios.
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.
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.
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.
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.
Germany’s center-right Union won the right on 23 February to head the governing coalition for the next four years, but the medtech industry’s first strong message is to ensure exports channels are not impeded by the imposition of US tariffs.
Cardiovascular detection and pharmacy legislation were put on hold last November when Germany's federal election was called. Martin Walger, chief executive of the IVDs industry association, the VDGH, discusses the hopes and fears of IVD companies in the run-up to the February 2025 vote.
The electronic patient record, a key piece of Germany’s new “DigiG” digital health law, was rolled out on 15 January, presaging more efficient delivery of targeted patient care and new opportunities for medical research informed by data.
When federal chancellor Olaf Scholz lost his parliamentary vote of confidence in mid-December, it officially opened up the way for the elections the German leader had already penciled in for 23 February. The medtech industry has not been slow to set out its demands of the incoming government.
The medtech sector in the UK, Switzerland, and Germany face a challenging 2025, heads of national trade groups say. Competition and access to innovation remain key concerns across the board, with collaboration with the EU and US planned in Switzerland while Germany focuses on approaching elections.
Bayer Consumer Health snaps up digital therapeutic Cara Care for its Precision Health business with an eye to developing its self-care capabilities.
“Flying blind” into healthcare reform was among the feisty criticisms of Germany’s proposed law on hospital care improvement during the final parliamentary plenary on 17 October. SPD health minister Karl Lauterbach has stoutly defended his reform.
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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.