Medtech trade groups in the UK, Switzerland, and Germany foresee a challenging 2025, leaders told Medtech Insight. 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.
Steve Lee & Phil Brown, regulatory directors, Association of British HealthTech Industries (ABHI)
On the UK medtech regulatory system, which is following a revised roadmap and new schedule of timings:
The UK regulatory system for Great Britain and Northern Ireland must balance robust patient safety standards with fostering innovation, ensuring access to new health technologies. It should harmonize with international frameworks to avoid duplication and facilitate market access, especially through pragmatic reliance and recognition routes with other key markets.
Clear, predictable pathways for technologies like AI and digital health could also provide an attractive opportunity to support growth and investment in the UK market.
To remain globally competitive, the system should streamline review timelines, adopt proportionate fees and strengthen post-market surveillance by integrating real-world data. Targeted support for SMEs will ensure the sector’s innovation engine remains strong and that transformative technologies can reach patients.
Luella Trickett, executive director, value and access, ABHI
On what the UK provider should do to ensure medtech innovations reach patients in a timely way:
The National Health Service must prioritize value-based procurement, moving away from a focus solely on unit cost to an assessment of the total value innovations bring across clinical pathways. This approach will encourage adoption of technologies that improve efficiency, reduce long-term costs and enhance patient outcomes.
The NHS also needs to address adoption by enhancing local resources for supporting the introduction of innovative technologies, including appointing chief innovation officers in NHS organizations to champion and oversee the introduction and use.
Standardizing real-world evidence frameworks and implementing a passport-based compliance approach will help streamline the introduction of proven technologies across NHS Trusts, ensuring timely and equitable patient access.
Daniel Delfosse, vice director and head of regulation and innovation, Swiss Medtech
On the triple program of regulatory actions that has turned the spotlight on Switzerland:
The formal signature of the mutual recognition deal [between Switzerland and the EU] is scheduled for spring 2025. A Swiss national consultation process will open before summer 2025. The federal council will decide on the nature of a referendum vote. The aim is for the Swiss parliament to deliberate on the deal in 2026.
Swiss Medtech hopes that the twin EU regulations will be reviewed in 2025, instead of having to wait until their originally scheduled review in 2027. The association is working closely with German and Austrian industry association counterparts, with which it co-signed a letter to the European Commission with 50 recommendations for MDR/IVDR improvements.
The Swiss authorities will submit a positioning letter on allowing US Food and Drug Administration-approved products into Switzerland to the federal council in the first quarter of 2025. The federal office of public health will receive an order to draft a regulation. We don’t know how long it will take, but it will happen.
Marcus Kuhlmann, head of medtech, Spectaris
On a year of change ahead for the German industry and market:
The German election is scheduled for 23 February. The biggest challenge for medtechs is the uncertainty and what will come next. But our biggest wish for the next coalition is that some kind of roundtables [in the model of those organized by Green Party minister for the economy, energy and climate change Robert Habeck] will be reestablished – and not as a temporary measure.
On the Krankenhausreform (hospital reform) that will begin to come into force on 1 January, Spectaris regretted not being allowed to have input into the debate on the composition of the 65 service groups setting out the equipment needed by hospitals, according to each hospital’s classification in the four-level scale of hospital expertise, known as Leistungsgruppen. But it is expected that the reform’s chief architect Karl Lauterbach will not retain the health portfolio in the forthcoming government, which Spectaris hopes will adopt a more consultative approach.
Germany’s medtechs call on the government to give them more support. If the government does not ensure that conditions improve soon, the industry will be going abroad and “Standort Deutschland,” or the competitive economic position of Germany, would be weakened.
The threat of US tariffs on imports of German medtech goods are a further cause for industry concern in 2025.
Editor’s Note: Some answers have been slightly edited for brevity and clarity.
