EU Commission 2025 Survey on Medical Device Availability

The EU Commission’s 2025 Economic Operator (EO) Survey on medical device availability reveals how MDR and IVDR implementation is impacting manufacturers, authorised representatives, importers, and distributors across the Union. Based on data as of 31 October 2024, the survey outlines certification progress, notified body timelines, documentation challenges, and emerging risks to device availability in the EU market. These insights are essential for companies navigating EU medical device regulatory compliance under MDR and IVDR.

Released on 1 December 2025, the 2nd EO Survey supports the European Commission’s multi-year study to monitor the availability of medical devices in the EU. The dataset spans responses from economic operators and presents its findings across 112 detailed slides, covering MDR/IVDR readiness, portfolio impacts, and operational challenges.

Key Findings from the 2025 EO Survey

• MDR/IVDR Certification Progress Remains Slow: Many manufacturers have only partially transitioned their portfolios. The survey highlights persistent bottlenecks in technical documentation reviews and QMS assessments, with notified bodies facing sustained high demand.

• Submission Issues Are a Major Barrier: Common issues include incomplete technical files, insufficient clinical evidence, inconsistent formatting, and unclear device intended use—all contributing to extended lead times during notified body review.

• Market Withdrawals and Product Discontinuations: A large number of companies reported discontinuing one or more devices. Low-volume, niche, and legacy products are at highest risk, raising concerns about EU-wide access to specialised medical devices.

Impact on the EU Medical Device Industry

The findings indicate several structural impacts:

• Reduced availability of niche or low-revenue devices

• Extended MDR/IVDR timelines and administrative burden

• Higher compliance costs, affecting smaller manufacturers most

• Potential supply gaps and long-term risk to EU healthcare systems

These challenges influence market sustainability, investment decisions, and innovation pipelines across the MedTech sector.

Actions for Manufacturers in 2025–2026

1. Strengthen Early Regulatory Preparation: Begin MDR/IVDR submissions early, build schedule buffers, and ensure documentation completeness before approaching notified bodies.

2. Prioritise Critical Product Lines: Focus on high-risk or high-demand devices first to limit potential market gaps.

3. Continuously Monitor EC Guidance: Regulatory updates, grace-period adjustments, and capacity announcements directly impact certification strategy.

Internal Link  

• EU Medical Device Classification & Regulation (MDR/IVDR)

• EU IVDR Consulting

• EU MDR Consulting

External Link Suggestions  

• European Commission official survey page

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