Germany

Pragmatic solutions are called for to ensure that German medical device manufacturing and innovation remain competitive in global terms, federal health minister Nina Warken told a hearing of medtech industry leaders.

Inaugural cabinet office dialog session leaves German medtech optimistic about increasing central government support in the coming months, say trade associations in Medica preview.

Parliament will debate the KHAG hospital reform adjustment law proposal in November, but opinion is split over the value of the new delivery model for German inpatient care.

Industry survey points to ongoing low revenues rise and weaker profit levels for half of BVMed industry association members in 2025, as German manufacturers raise stakes on global harmonization.

At LSX World Congress USA, medtech executives shared lessons on global expansion, from regulatory pitfalls to cultural nuances and funding gaps. Their message: Prepare early, secure capital, and choose partners wisely.

Berlin medtech associations add to European voice requesting that the EU eases MDR/IVDR and other compliance costs on SMEs.

Germany’s electronic patient record – ePA – is a flagship initiative of the ongoing national healthcare reform. The medtech industry welcomes rollout of the ePA while calling for further improvements.

IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.

Amendments to Germany’s – barely in force – health reform law will be decided after the summer break. The new DRGs payments plan and service groups will be reviewed, but critics fear for the law’s future.

Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.

2026 reimbursement calculations for the list of hybrid DRGs – a mechanism to incentivize day cases over inpatient surgery – will be issued in few weeks’ time. The medtech industry has made its demands known.

EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.

Germany’s CorTec has implanted its wireless brain-computer interface in a stroke patient, launching a trial to test safety and whether brain stimulation during physical therapy can help restore movement where traditional rehab has failed.

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

Less bureaucracy, no more national supply chain law, framework agreements and competition for direct reimbursement of medtech innovations are among the positive changes the local medtech industry might expect as Germany’s new government gets down to work. Life sciences lawyer Gunnar Sachs offers a view from the ground.

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.