In view of the feedback from 245 participating manufacturers from Germany, Austria and Switzerland, the associations are calling for a swift and targeted revision of both sets of regulations. "The results are a wake-up call," the four associations jointly declare. "The MDR and IVDR urgently need to be readjusted, otherwise Europe will lose its innovative strength and security of supply. We need regulation that enables innovation instead of preventing it."
According to BVMed, Medical Mountains, SPECTARIS and VDGH, the survey results clearly show that the MDR and IVDR do not achieve their original objectives - safety, health protection, transparency and innovation. "Instead of promoting innovation, the current regulations are leading to a massive decline in research and development activities, the relocation of innovations and, in some cases, production abroad, as well as a shift in value creation and expertise to other jurisdictions - above all America and Asia," states the results report, which was presented to EU Health Commissioner Olivér Várhelyi, among others. Overall, this leads to a loss of competitiveness and attractiveness as a business location, as well as to endangered supply chains and impending supply gaps - especially for niche products, so-called orphan devices.
"As a result, Europe is at risk of losing its leading role as a medtech location and jeopardizing patient and supply safety in the EU. A targeted revision of the MDR and IVDR is therefore essential," say the associations. This includes simplified procedures, proportionate requirements and relief for small and medium-sized companies in particular. The four MedTech associations demand: "The necessary adjustments must be adopted and implemented promptly in order to set the course for a regulatory system that enables innovation, ensures long-term competitiveness and at the same time guarantees a high level of patient safety."
Key survey results
The survey data shows clear negative effects of the MDR and IVDR on the innovative strength and competitiveness of companies and the market availability of products in Germany and the EU.
Decline in research and development
53% of respondents report a reduction in their research and development (R&D) projects in the last five years due to the MDR and IVDR. 46 percent of these companies reported a decline of over 75 percent. In addition, 20 percent of the responding companies have reduced their R&D staff. The decline particularly affected in-vitro diagnostics. Despite these declines, R&D continues to take place predominantly in the EU.
Shifting the market launch of innovations to non-EU countries
Over 40 percent of the responding companies no longer launched innovative products in the EU. Instead, more than half of these products were launched in other markets - first and foremost in the USA, followed by Asia, South America and Canada.
Special national requirements within the EU as an obstacle within the internal market
38% of respondents state that they cannot offer certain products in all EU member states due to special national regulatory rules (e.g. language requirements, national databases) - including in Slovakia, Hungary, Croatia and Romania.
Decline in patent applications
22% of survey participants stated a decline in patent applications in the EU. The reasons cited include longer development and approval procedures, rising costs and a significant shift of resources to regulatory activities.
Production sites in the EU under pressure
Around a third of the responding companies are planning to relocate some or all of their production outside the EU. The main reasons for this include rising energy costs, a shortage of skilled workers, high wage costs, regulatory burdens and increasing bureaucracy.
Unstable supply chains
Almost three quarters of respondents report disruptions in their supply chains in the last five years. In addition to global factors such as raw material bottlenecks and trade tariffs, regulatory requirements in the EU were also cited as a key negative factor.
Orphan devices particularly at risk
Of the manufacturers that produce orphan devices, 64% stated that they had already discontinued products due to the MDR/IVDR. This poses the threat of significant gaps in supply for particularly vulnerable patient groups.
Background to MDR and IVDR
The MDR and IVDR were adopted with the aim of creating a modern, transparent and reliable legal framework that ensures a high level of safety and health protection while promoting innovation. However, since their binding entry into force in May 2021 (MDR) and May 2022 (IVDR), it has become clear that their implementation poses considerable challenges for the entire industry - with noticeable consequences for the innovative strength, product availability, competitiveness and resilience of the European healthcare industry. Against this backdrop, the EU Parliament, member states and industry associations have repeatedly called for the two legal frameworks to be simplified and modernized.
The European Commission has already started to review the two regulations in 2024. The results of this review are to lead to concrete legislative proposals. In particular, the aim is to reduce bureaucracy, speed up procedures, increase predictability and cost efficiency and ensure the future viability of the European medtech and in-vitro diagnostics industry.
To support this process, BVMed, MedicalMountains, SPECTARIS and VDGH conducted a comprehensive survey of manufacturers in Germany, Austria and Switzerland in the summer of 2025. The aim was to create a current picture of the impact of the MDR and IVDR on innovation, competitiveness, resilience, product availability and the special situation of orphan devices.
The four associations have already submitted concrete solutions to this issue in separate papers and statements to the European Commission. The VDGH refers in particular to its statement on the European Simplification Initiative, the position paper on SMEs in medical technology and the white paper on the further development of the MDR/IVDR. These documents show how targeted adjustments can strengthen innovation, competitiveness and security of supply in equal measure.
About the survey
The online survey took place from June 15 to August 31, 2025. A total of 267 companies took part, 245 of which were manufacturers whose responses were included in the analysis.
78% produce medical devices and accessories in accordance with the MDR, 10% in-vitro diagnostics in accordance with the IVDR. 12 percent are manufacturers according to both sets of regulations.
The headquarters of 209 manufacturers are located in Germany, with other participants coming from Switzerland (11), Austria (5) and other EU and non-EU countries (20). The spectrum ranged from micro companies (<10 employees, 9 percent), small companies (10 to 49 employees, 23 percent), SMEs (up to 249 employees, 31 percent) and small and mid-cap companies (up to 750 employees, 13 percent) to large companies (>750 employees, 24 percent).
84% of the participating companies have been active in research and development (R&D) in the past ten years. 91% operate at least one production site in the EU. The results are therefore highly significant for the European market.
As German manufacturers have a disproportionately high market share of around 60 billion euros - almost half of the EU-wide industry turnover - the results can also be interpreted as a trend for the entire European medtech industry.
