New MDR/IVDR Survey Finds Europe’s MedTech Innovation Engine is Slowing
Six takeaways from BVMed’s very revealing 2025 D-A-CH industry survey.
As Europe continues to revise its flagship regulations for medical devices (MDR) and in-vitro diagnostics (IVDR), a new joint survey from four leading medtech associations paints a sobering picture of their real-world impact so far.
Between June and August 2025, BVMed (Germany), MedicalMountains, SPECTARIS, and VDGH surveyed 267 companies across Germany, Austria, and Switzerland, collecting 245 manufacturer responses.
Their conclusion is pretty blunt: rather than strengthening innovation, competitiveness, and patient access, the MDR and IVDR have triggered widespread R&D pullbacks, supply chain fragility, and product withdrawals, especially among orphan device makers.
The four associations conclude that the MDR and IVDR are “failing to achieve their original objectives of safety, health protection, transparency, and innovation.” Their joint statement urges the European Commission to adopt simpler, more proportionate, SME-friendly revisions that restore competitiveness while maintaining safety.
The Commission’s ongoing review (initiated in 2024) aims to reduce bureaucracy, speed approvals, and stabilize Europe’s role as a MedTech manufacturing and R&D hub. Concrete proposals are expected in 2026.
Below, we summarize the findings most relevant to regulatory and quality professionals evaluating supplier resilience and market readiness going into 2026.
1. R&D activity is contracting across the sector
53% of manufacturers say they’ve reduced R&D over the past five years because of MDR/IVDR burdens—nearly half of those by more than 75%. 20% also report downsizing R&D teams, particularly in in-vitro diagnostics.
While most firms continue R&D within the EU, many describe making a pivot from innovation toward regulatory survival.
2. Innovators are launching outside the EU first
Roughly four in ten respondents no longer introduce new products in the EU at all. More than half of those now debut in the United States, followed by Asia and Latin America.
Longer review timelines, higher compliance costs, and unpredictable notified-body capacity are pushing firms toward U.S.-first strategies—a seeming reversal of Europe’s historical position as the launch market of choice.
3. Fragmentation inside the “single market” is growing
38% of respondents say national special requirements (like extra database entries or translation rules) prevent them from marketing certain products across all EU member states.
Markets such as Slovakia, Hungary, Croatia, and Romania were most often cited. This growing patchwork undermines the regulatory harmonization MDR/IVDR were meant to achieve in the first place and creates logistical and vigilance challenges for manufacturers and importers alike. (We’ve heard this from firms ourselves trying to market products across the EU.)
4. Patent filings and production are shifting outward
One in five companies reports a decline in EU patent applications, attributing it to prolonged development cycles and resource diversion to regulatory documentation.
At the same time, about a third are planning to relocate some or all production outside the EU—pointing to regulatory costs alongside energy prices and skilled-labor shortages.
Respondents warn this could further erode the continent’s manufacturing base and increase dependence on imports for critical medical products.
5. Supply chains are unstable (and regulation is partly to blame)
Nearly three-quarters of manufacturers have faced supply chain disruptions in the past five years. While global factors like raw-material shortages and logistics bottlenecks play a role, respondents explicitly highlight EU regulatory complexity (supplier re-certifications, labeling updates, and document backlogs) as a significant internal driver. Several note that small sub-suppliers have lost ISO 13485 certification or exited the market entirely, amplifying the continuity risk.
6. Orphan devices are disappearing from the market
Among companies producing so-called orphan devices—low-volume, high-need products serving small patient populations—64% report discontinuing at least one product because of MDR/IVDR.
These losses disproportionately affect vulnerable patient groups and hospitals reliant on specialized implants or diagnostics. The associations behind the survey call the situation a “security-of-supply threat” demanding urgent regulatory relief.
Read the full press release here (in German).
A few potential implications for RA/QA and supply leaders
Several implications come to mind immediately based on this survey and the anecodates we’ve gathered through working with firms marketing devices in the EU.
Expect more U.S.-first launches. European suppliers may increasingly seek early alignment with FDA requirements. Dual-format documentation and pre-submission harmonization will be essential, and we’re already seeing firms come to us for regulatory support to do exactly that.
Audit suppliers for continuity risk. MDR/IVDR stressors are now a real factor in supply stability. Prioritize EU-based critical suppliers for 2026 audit cycles if you haven’t already.
Plan for potential manufacturing relocation. Maintain verified tech-transfer and re-qualification plans should key suppliers move production outside the EU. We’re seeing some of this, too.
Anticipate heavier documentation loads. Resource diversion from R&D to regulatory tasks means greater need for experienced QA/RA consultants to prevent backlogs and inspection delays. Talk to us if you need extra heads or hands to take on the documentation workload here.
Europe’s regulatory pendulum may be swinging too far toward control at the expense of innovation and access. For global firms (and their U.S. partners) the message is clear: vigilance, dual-market readiness, and proactive supplier oversight are now non-negotiable.
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