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

Medical device availability across the European Union remains a major regulatory, public health, and market continuity priority as the implementation of the Medical Device Regulation (EU) 2017/745 (MDR) continues to reshape compliance expectations.

To better understand the real-world impact of MDR implementation, the European Commission has conducted multiple structured stakeholder surveys involving:

• Medical device manufacturers 
• Authorized Representatives (ARs) 
• Notified Bodies 
• Health Service Providers (HSPs) 
• Other Economic Operators (EOs) 

On December 1, 2025, the European Commission released the Second Survey on Economic Operators (EOs), providing important insights into:

• MDR certification readiness 
• EUDAMED adoption trends 
• Notified Body engagement timelines 
• Certification delays 
• Device availability concerns 
• Operational preparedness across the EU market 

The findings offer a practical, evidence-based view of where MDR implementation currently stands and where manufacturers must focus strategically to avoid regulatory disruption and maintain uninterrupted EU market access.

At Maven Regulatory Solutions, we support manufacturers and Authorized Representatives with MDR transition planning, technical documentation remediation, EUDAMED compliance, Notified Body engagement strategies, and post-market regulatory support aligned with evolving European Commission expectations.

Overview Of the Second Economic Operators (EO) Survey

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

December 19, 2024 – March 21, 2025

The objective was to assess:

• MDR implementation progress 
• Market readiness 
• Certification timelines 
• Regulatory bottlenecks 
• Device availability risks 

Survey Scope and Methodology

Key Survey Statistics

Although the total number of invited participants was not disclosed, the survey provides meaningful insight into MDR system performance and certification readiness trends.

EUDAMED Actor Module Adoption: Strong Industry Alignment

One of the most significant findings was the exceptionally high voluntary adoption rate of the EUDAMED Actor Module.

Key Finding

95% of surveyed manufacturers and Authorized Representatives were already voluntarily registered in the EUDAMED Actor Module.

This is particularly important considering:

• Increasing EUDAMED operational rollout 
• Commission Implementing Decision (EU) 2025/2371 
• Growing digital compliance expectations under MDR 

Why EUDAMED Adoption Matters

The high adoption rate demonstrates:

• Strong alignment with EU digital regulatory infrastructure 
• Improved traceability across supply chains 
• Better transparency for Competent Authorities 
• Increased readiness for future mandatory module deployment 
• Growing regulatory maturity among Economic Operators 

For manufacturers seeking long-term EU market continuity, early EUDAMED adoption is increasingly becoming an operational expectation rather than a voluntary best practice.

MDR Application Preparation Timelines

The survey also evaluated the amount of time manufacturers require to prepare MDR applications.

Average Manufacturer Preparation Timeline

Manufacturers reported an average preparation period of:

6–12 months

Activities Included Within MDR Preparation

The preparation phase commonly includes:

• MDR gap assessments 
• Technical documentation remediation 
• Clinical evaluation updates 
• PMS and PMCF alignment 
• QMS updates 
• EUDAMED registration 
• Notified Body preparation activities 
• Labeling and UDI updates 

Regulatory Insight

The survey reinforces a major industry reality:

MDR compliance cannot be approached as a last-minute regulatory activity.

The data confirms that successful MDR transition requires:

• Long-term planning 
• Cross-functional coordination 
• Early technical remediation 
• Proactive Notified Body engagement 

This is especially important for:

• Legacy devices 
• Higher-risk devices 
• Devices transitioning from MDD/AIMDD certification 

Notified Body Engagement Timelines

The survey compared manufacturer-reported onboarding timelines with data from the 12th Notified Body Survey.

Average Timeline: Application To Signed Agreement

Manufacturers reported:

1–3 months

for the period between:

• Initial application submission 
• Screening and review 
• Resource allocation 
• Contract execution 

What This Indicates

The findings suggest improved operational efficiency among Notified Bodies in areas such as:

• Initial application handling 
• Client onboarding 
• Resource planning 
• Contract management 

Important Regulatory Takeaway

Contrary to earlier industry concerns, the survey indicates that:

Initial Notified Body engagement itself is not currently the primary MDR bottleneck.

Instead, longer delays are more commonly associated with:

• Documentation quality issues 
• Clinical evidence deficiencies 
• Technical remediation requirements 
• Iterative conformity assessment cycles 

MDR Certification Timelines Remain Extended

Although onboarding timelines appear stable, overall MDR certification timelines remain lengthy.

Time To MDR QMS & Product Certification

Why Certification Delays Continue

The discrepancy between manufacturer and Notified Body timelines likely reflects:

• Underestimation of remediation complexity 
• Multiple rounds of technical questions 
• Clinical evidence deficiencies 
• PMCF gaps 
• QMS nonconformities 
• Resource limitations during review cycles 

Devices Most Likely to Experience Delays

Certification delays remain especially significant for:

• Legacy MDR transition devices 
• Class III devices 
• Implantable devices 
• Devices requiring PMCF strengthening 
• Software and digital health technologies 
• Combination products 

Public MDR Dashboard: Greater Regulatory Transparency

The European Commission’s MDR Public Dashboard aggregates data from:

• EO Surveys 
• Notified Body Surveys 
• MDCG working groups 
• Stakeholder interviews 
• Regulatory monitoring activities 

Key Public Dashboard Finding

under the MDR Outcomes section:

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

Why This Matters

These findings challenge earlier assumptions regarding a severe Notified Body capacity crisis.

The data indicates that:

• Most Notified Bodies remain operationally open 
• Capacity exists for new applications 
• Delays are often linked to manufacturer readiness rather than access alone 

Strategic Implication for Manufacturers

Manufacturers should prioritize:

• Documentation quality 
• Clinical evidence robustness 
• Technical file readiness 
• QMS maturity 
• Submission strategy optimization 

Preparation quality increasingly has greater impact than Notified Body selection alone.

Health Service Providers (HSP) Survey

In parallel with EO and Notified Body surveys, the European Commission also conducted a Health Service Providers (HSP) Survey.

HSP Survey Details

Important Study Limitation

The HSP survey was considered non-representative due to:

• Limited participant numbers 
• Difficulty reaching healthcare providers 
• Narrower sampling scope 

Why The HSP Survey Still Matters

Despite limitations, the survey still provides useful insight into:

• Device availability concerns 
• Procurement continuity risks 
• Supply-chain disruption signals 
• Clinical access concerns 
• Downstream MDR impacts on healthcare delivery 

The findings help contextualize manufacturers and Notified Body survey data.

Key MDR Timeline Insights

Stakeholder Survey Overview

Strategic Implications for Medical Device Manufacturers

The combined survey findings reveal several important industry trends.

1. MDR Processes Are Stabilizing

The data suggests that MDR implementation is progressing gradually rather than collapsing under systemic bottlenecks.

2. Early Planning Is the Strongest Success Factor

Manufacturers with structured MDR transition strategies are significantly better positioned to maintain uninterrupted market access.

3. Documentation Quality Drives Timelines

Long certification timelines are increasingly linked to:

• Weak clinical evidence 
• Incomplete technical files 
• Poor PMS integration 
• Insufficient PMCF planning 

4. EUDAMED Is Becoming Operationally Mandatory

Although some EUDAMED modules remain voluntary, the industry is rapidly moving toward fully digital regulatory integration.

5. Certification Delays Are Often Preventable

Well-prepared submissions can significantly reduce:

• Technical questions 
• Nonconformities 
• Iterative review cycles 
• Approval delays 

Impact On Medical Device Companies

Organizations with strong MDR governance programs remain best positioned for long-term EU market success.

Emerging MDR Trends In 2025–2026

Key Trends Include

• Increased EUDAMED adoption 
• Greater digital regulatory integration 
• Enhanced clinical evidence scrutiny 
• Stronger PMS and PMCF expectations 
• More structured NB review methodologies 
• Improved MDR system transparency 
• Increased reliance on public regulatory dashboards 
• Stronger lifecycle compliance expectations 

Quick Facts

• 95% of surveyed manufacturers and ARs voluntarily registered in EUDAMED 
• MDR application preparation averages 6–12 months 
• Application-to-contract timelines average 1–3 months 
• MDR certification commonly exceeds 13–19 months 
• 49 of 50 Notified Bodies are accepting new clients 
• Documentation quality remains a major delay factor 
• Early MDR planning significantly improves success rates 
• EUDAMED adoption is rapidly becoming standard practice 

Why This Matters

Manufacturers that fail to prepare proactively may face:

• MDR certification delays 
• EU market disruption risks 
• Increased Notified Body findings 
• Clinical evidence deficiencies 
• EUDAMED compliance gaps 
• Recertification bottlenecks 
• Increased regulatory scrutiny 
• Loss of market continuity 

Organizations with structured MDR transition programs will be significantly better positioned to maintain uninterrupted EU market access.

How Maven Regulatory Solutions Supports MDR Success

Our Services

• MDR gap assessments and transition planning 
• Technical documentation remediation 
• Clinical evaluation and PMCF support 
• EUDAMED Actor Module registration support 
• QMS alignment and audit readiness 
• Notified Body engagement strategy 
• Regulatory intelligence monitoring 
• PMS and vigilance integration 
• MDR lifecycle compliance management 

Why Choose Maven

• Deep expertise in EU MDR implementation 
• Strong clinical and technical documentation capabilities 
• Practical regulatory strategy support 
• Up-to-date MDR intelligence tracking 
• End-to-end compliance guidance 
• Experience supporting global MDR transition projects 
• Structured approaches to reducing certification delays 

Learn more at Maven Regulatory Solutions.

Need Support with EU MDR Compliance and Certification Readiness?

Maven Regulatory Solutions helps manufacturers and Authorized Representatives navigate evolving MDR requirements with confidence.

We Help You With

• MDR transition strategies 
• Technical documentation remediation 
• Clinical evaluation updates 
• EUDAMED registration support 
• PMCF and PMS integration 
• Notified Body engagement 
• Audit readiness preparation 
• Regulatory intelligence monitoring 

Partner With Maven Regulatory Solutions To:

• Reduce MDR certification delays
• Improve technical documentation quality
• Strengthen EUDAMED readiness
• Enhance audit preparedness
• Maintain uninterrupted EU market access
• Build long-term MDR compliance resilience

Contact Maven Regulatory Solutions today to strengthen your MDR transition and market continuity strategy.

Conclusion

The European Commission’s Second Economic Operators Survey provides encouraging evidence that MDR implementation is gradually stabilizing, supported by strong EUDAMED adoption and continued Notified Body engagement capacity.

At the same time, the data clearly confirms that MDR certification remains a highly evidence-intensive and resource-demanding process requiring early preparation, strong clinical documentation, mature quality systems, and strategic regulatory planning.

Manufacturers that invest proactively in structured MDR transition programs, robust documentation remediation, and digital compliance readiness will remain best positioned to maintain long-term access to the European medical device market.

FAQs

1. What is the EU MDR Second Economic Operators Survey?

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

2. Is EUDAMED registration mandatory?

While full mandatory implementation is still evolving, voluntary registration is rapidly becoming an industry expectation.

3. How long does MDR certification typically take?

Survey findings indicate that MDR QMS and product certification commonly require 13–19+ months.

4. Are Notified Bodies still accepting new MDR clients?

Yes. According to the public MDR dashboard, 49 out of 50 Notified Bodies reported accepting new MDR clients.

5. What causes most MDR certification delays?

Common causes include incomplete technical documentation, clinical evidence gaps, PMCF deficiencies, and QMS nonconformities.

6. Why is early MDR planning important?

MDR preparation often requires 6–12 months before submission and helps reduce delays during conformity assessment.

7. How does EUDAMED improve compliance?

EUDAMED enhances traceability, transparency, digital submissions, and market surveillance coordination across the EU.

8. How can Maven help with MDR compliance?

Maven supports MDR transition planning, technical documentation remediation, EUDAMED registration, Notified Body engagement, and ongoing lifecycle compliance support.