EU MDR Medical Device Availability: Key Insights From The European Commission’s Second Economic Operators Survey (2025)

Medical device availability in the European Union remains a critical regulatory and public health priority as the Medical Device Regulation (EU) 2017/745 (MDR) continues to reshape market access requirements. To assess real-world impacts, the European Commission has conducted a series of structured surveys targeting manufacturers, Authorized Representatives (ARs), Notified Bodies, and Health Service Providers.

On December 1, 2025, the European Commission published the Second Survey on Economic Operators (EOs), offering valuable insight into MDR preparedness, certification timelines, EUDAMED registration trends, and Notified Body engagement.

For manufacturers, legal manufacturers, ARs, and regulatory professionals, these findings provide an evidence-based view of where MDR implementation stands and where strategic planning is essential to avoid market disruption.

This article breaks down the key findings, regulatory implications, and strategic insights from the Second EO Survey, the public MDR dashboard, and the Health Service Providers (HSP) survey through a practical, compliance-focused lens.

Overview of the Second Economic Operators (EO) Survey

The Second Survey on Economic Operators was conducted via the EU Survey platform between:

• December 19, 2024 – March 21, 2025

Survey Scope and Methodology

• Validated respondents: 254
• Target participants:
  • Medical device manufacturers
  • Authorized Representatives (ARs)
• Questionnaire size: 81 questions
• Response rate: Not disclosed by the study team
• Geographical coverage: EU/EEA Economic Operators

Although the total number of Economic Operators contacted was not disclosed, the dataset provides statistically relevant insights into MDR certification readiness and system performance.

EUDAMED Actor Module Adoption: A Strong Compliance Signal

One of the most notable findings from the survey is the high level of voluntary registration in EUDAMED.

Key Insight

• 95% of surveyed manufacturers and ARs were already voluntarily registered in the EUDAMED Actor Module

This is a significant compliance indicator, particularly considering Commission Implementing Decision (EU) 2025/2371, which strengthens expectations around EUDAMED usage.

Why This Matters

• Demonstrates strong industry alignment with EU digital regulatory infrastructure
• Reduces friction for future mandatory EUDAMED module rollouts
• Enhances traceability, transparency, and market surveillance
• Signals growing regulatory maturity among Economic Operators

For companies planning EU market continuity, early EUDAMED adoption is increasingly becoming a baseline expectation rather than a best practice.

MDR Application Preparation Timelines: Manufacturer Perspective

When comparing the Second EO Survey to the first manufacturer/Authorized Representative survey (September 2024), preparation timelines show consistency.

Reported Time to Prepare MDR Applications

• 6–12 months on average

This preparation period typically includes:

• MDR gap assessment
• Technical documentation remediation
• Clinical evaluation updates
• QMS alignment with MDR
• EUDAMED registration
• Notified Body engagement readiness

Regulatory Insight

A 6–12-month preparation timeline underscores that MDR compliance is not a last-minute activity. Early planning remains critical, particularly for legacy devices transitioning from MDD/AIMDD.

Notified Body Engagement: Application to Contract Timelines

The Second EO Survey also compared manufacturer-reported timelines with data from the 12th Notified Body Survey.

Average Time from Application Lodgment to Signed Agreement

• 1–3 months

This indicates improved operational efficiency in:

• Application screening
• Resource allocation
• Contract finalization

Key Takeaway

Contrary to earlier concerns, initial Notified Body engagement does not appear to be a primary bottleneck in MDR certification.

Time to MDR Certification: Where Delays Still Occur

Despite faster onboarding, certification timelines remain extended.

Time to MDR QMS & Product Certification

Interpretation

The discrepancy highlights:

• Underestimation of remediation complexity by manufacturers
• Iterative review cycles for clinical evidence
• Nonconformities in QMS implementation
• Resource constraints during conformity assessment

Regulatory Reality

MDR certification remains a multi-phase, evidence-intensive process, especially for:

• Legacy devices
• Higher-risk classifications
• Devices requiring PMCF strengthening

Public MDR Dashboard: Transparency into System Performance

The European Commission’s Public Dashboard aggregates insights from:

• EO surveys
• Notified Body surveys
• Stakeholder interviews
• MDCG Taskforce meetings

Key Finding: Notified Body Capacity

Under the MDR Outcomes tab:

• 49 out of 50 Notified Bodies confirmed they are accepting new MDR clients

What This Means

• There is no systemic Notified Body capacity crisis
• Delays are more often linked to documentation quality, clinical gaps, and readiness
• Strategic preparation is more impactful than Notified Body selection alone

Health Service Providers (HSP) Survey: A Complementary View

In parallel, a Health Service Providers (HSP) survey was conducted to assess downstream impacts.

Survey Details

• Survey period: August 14, 2024 – October 31, 2024
• Publication date: May 8, 2025
• Responses received: 65
• Validated for analysis: 55

Study Limitation

The survey was declared non-representative due to:

• Difficulty reaching HSP groups
• Limited sample size

Why It Still Matters

Despite limitations, the HSP survey provides:

• Early signals of device availability concerns
• Insights into procurement and continuity risks
• Contextual validation of EO and Notified Body data

Key Timeline Insights from EU MDR Surveys

Key Stakeholder Survey Coverage

Strategic Implications for Medical Device Companies

The combined survey data clearly indicates:

• MDR processes are stabilizing, not stagnating
• Early regulatory planning is the strongest success factor
• Documentation quality outweighs procedural speed
• Digital compliance tools (EUDAMED) are becoming mandatory in practice
• Certification delays are preventable with structured MDR programs

How Maven Regulatory Solutions Supports MDR Success

Maven Regulatory Solutions enables medical device manufacturers and Authorized Representatives to navigate MDR with confidence through:

• MDR gap assessments and transition strategies
• Technical documentation and clinical evaluation remediation
• QMS alignment and audit readiness
• EUDAMED Actor Module registration and compliance support
• Notified Body engagement and submission strategy
• Post-market surveillance and PMCF integration

Our first regulatory approach is regulatory focused on reducing certification timelines, preventing avoidable nonconformities, and protecting EU market access.

Conclusion

The European Commission’s Second Survey on Economic Operators provides reassuring evidence that EU MDR implementation is progressing supported by increasing EUDAMED adoption and stable Notified Body capacity. However, the data also reinforces a critical message: MDR success depends on preparation, not proximity to deadlines.

Manufacturers that invest early in regulatory strategy, clinical evidence, and system alignment are best positioned to maintain uninterrupted access to the EU market.

FAQs: EU MDR Survey & Device Availability

1. What is the Second EO Survey under EU MDR?

It is a European Commission survey assessing MDR preparedness, certification timelines, and operational challenges faced by manufacturers and Authorized Representatives.

2. Is Notified Body capacity still a concern?

Survey data shows that nearly all Notified Bodies are accepting new clients, indicating capacity is not the primary bottleneck.

3. Why does MDR certification still take over 18 months?

Delays are often linked to clinical evidence gaps, QMS nonconformities, and iterative documentation reviews.

4. Is EUDAMED registration mandatory?

While not fully mandatory yet voluntary registration is rapidly becoming an industry expectation ahead of full enforcement.

5. How can companies reduce MDR approval timelines?

Early gap assessments, robust clinical strategies, and structured MDR submission planning significantly reduce delays.