Euro Roundup: Swiss Federal Council advances effort to ease import of FDA-authorized devices

The Swiss Federal Council this week reached a decision on how to implement a recent motion that would make it easier to place medical devices that have been authorized by the US Food and Drug Administration (FDA) on the Swiss market.

The Federal Council said it will task independent private entities to conduct a conformity procedure to ensure that they meet Swiss requirements as it works toward implementing Motion 20.3211.

“These bodies will review the relevant conditions under a simplified conformity assessment procedure, taking into account elements already performed by the FDA,” the Federal Council said. Specifically, the Federal Council said that local data protection and quality management system requirements must be assessed and that a definition of a postmarketing surveillance plan will be needed.

Several government departments have been tasked with exploring the proposed approach in detail before a legislative proposal is brought forward.

Industry lobby group Swiss Medtech praised the move but urged the government to speed adoption of the proposal. “Swiss Medtech welcomes this important step, which will ensure the security of supply, increase innovation in the medtech sector, and promote our country as a centre of production. Our association requires that appropriate steps be taken quickly: in view of the uncertain supply situation, there is no time to lose! Rapid implementation at the ordinance level is not only possible, but absolutely essential,” the group said.

Announcement, Swiss Medtech statement

MedTech Europe warns trade tensions, tariffs pose an existential threat to industry

MedTech Europe is calling for urgent action to address trade tensions and tariff threats that it sees as an existential threat to its industry, patients, healthcare professionals and health systems.

The trade group joined with other medtech associations to set out its concerns in an open letter to the European Commission president Ursula von der Leyen. MedTech Europe and its co-signatories used the letter to “urgently call for a direct dialogue” with von der Leyen to address the “impending crisis.” Noting the importance of the US as a trading partner, the groups framed tariffs as a threat to device supply.

“Our industry strongly supports your proposal for ‘Zero-for-Zero’ tariffs on trade in industrial goods between Europe and the United States, and urges you in the strongest possible terms to protect public health, by promoting an extension of the Zero-for-Zero proposal to all medical technologies, and to the essential components needed to produce them,” the trade groups told von der Leyen.

Many of the 2 million medical technologies sold in Europe are “highly complex and rely on intricate, globally-integrated supply chains,” MedTech Europe said. Tariffs can increase the costs of components, spare parts and raw materials used to make and maintain medical devices, the trade groups said, and in turn threaten the availability of products.

Companies in all industries have been reassessing their supply chains in light of the tariffs imposed and threatened by the Trump administration. The trade group said substituting raw materials or components that are critical to medtech products “necessitates validation to ensure the technology remains safe and performs as intended,” assuming alternative sources are available.

Substitutions pose particular challenges in the European Union. The trade groups said that, unlike many other jurisdictions, the EU can mandate re-certification in cases where materials or components need to be changed. “This can prevent or delay patient access to needed technologies,” MedTech Europe said.

The trade groups used the letter to make a broader complaint, arguing that the tariff threat comes at a time when the medtech sector is “already experiencing shortages, an innovation drain and the risk of SMEs closing business due to European regulatory frameworks.” The frameworks are “excessively costly, time-consuming and unpredictable” compared to the regulations in other regions, the trade groups said.

Press Release, Open Letter

EFPIA-ordered report finds AMR vouchers will cost 45% less than Commission’s estimate

A report ordered by EFPIA has found the proposed antimicrobial resistance (AMR) voucher scheme will cost 45% less than previously estimated by the European Commission.

The Commission proposed creating transferable exclusivity vouchers (TEVs) to give antibiotic developers an additional 12 months of regulatory data protection. Companies could use the vouchers to extend the period of exclusivity for one of their own products or sell the TEV to another company. The Commission estimated the scheme would cost public payers €294 million ($333 million) per voucher per year.

Amid questions about the value of the scheme, the European Parliament and Council proposed placing restrictions to control costs. Pharma trade group EFPIA tasked Charles Rivers Associates with studying the likely impact of TEVs to inform the debate.

The report estimated each TEV will cost public payers €162 million a year. The difference between the EFPIA and Commission estimates stems from changes to the eligibility criteria under a revised legislative proposal. The changes restrict the use of TEVs to products within the fifth year of regulatory protection and prevent their application to drugs that exceeded €490 million in annual sales in the first four years.

EFPIA’s report also looked at what individual EU countries will pay and the cost of inaction. The average cost to EU countries will be €6 million, according to the report, and Germany, France, Italy and Spain are the only countries that will pay more than €7.1 million.

The estimated cost of AMR exceeds the forecast spending per TEV in every country bar Estonia, where the figures are equal. In France, the forecast costs are €28 million per TEV and €264.3 million for AMR. The findings informed a warning against imposing further restrictions on the proposed scheme.

“It is important to acknowledge that while the restrictions proposed to the draft TEV legislation by the European Parliament and Council may result in lower costs to Member States, they will also weaken the value of TEV to antimicrobial developers and hence weaken the incentive,” the report concluded. “These results also mean that TEV alone will be unlikely to provide an incentive of sufficient scale.”

Press Release

EMA details proposals of CTIS Simplification Task Force, aims to implement changes in 2026

The European Medicines Agency (EMA) has published recommendations for making the Clinical Trials Information System (CTIS) more efficient and future-proof.

EMA, the Heads of Medicines Agencies and the European Commission set up the CTIS Simplification Task Force in early 2024. The organizations asked the task force to simplify CTIS business rules to enhance the user experience, improve operational stability, and optimize training and change management. The task force prioritizes topics based on user feedback and consults with stakeholders on a case-by-case basis.

EMA added details of the task force’s work to its CTIS website this week. The update shows the task force has identified 10 topics for analysis. The task force has finished analyzing six topics and recommended changes.

The recommendations include “the creation of a new safety module, with the aim to simplify the overall business rules for the Annual Safety Report while enabling the selection of the safety assessing Member State in CTIS,” EMA said. The task force also proposed “a revised roles matrix that reduces complexity by reducing the number of user roles.”

In contrast, the task force recommended keeping current processes for CTIS timetable visualization, Investigational Medicinal Product Dossier – Quality only applications and ad-hoc assessment. The task force will continue to monitor some of the topics and potentially implement improvements but the core processes are staying the same for now.

EMA said the task force expects the proposed changes to be implemented in CTIS from 2026. Work on four topics was either ongoing or yet to start when EMA summarized the task force’s activities, meaning there may be more recommendations to come.

EMA Notice, More

Switzerland takes steps to improve supplies of ‘urgently needed’ pediatric medicines

Swiss authorities have taken temporary action to “bridge acute shortages of medicinal products” while working to put a permanent fix in place.

The Swiss Agency for Therapeutic Products (Swissmedic) and other bodies have agreed to extend the meaning of the term “emergency” in the Medicinal Products Licensing Ordinance. The change will allow healthcare professionals to import urgently required medicinal products that are not authorized or not available in Switzerland even if they are not intended solely for one particular patient.

Swissmedic said the change will “improve the supply of urgently needed pediatric medicinal products.” The extended definition of “emergency” will apply until an ongoing amendment of the Ordinance enters into force.

Swissmedic Notice

Other News:

EMA’s management board has unanimously recommended renewing Emer Cooke’s mandate. Cooke is set to complete her first term as head of EMA in November. The management board has recommended extending Cooke’s mandate until 1 May 2027, her pension age. EMA Notice

Euro Roundup: Swiss Federal Council advances effort to ease import of FDA-authorized devices

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