Team-NB Medical Device Survey 2025: What The Latest MDR & IVDR Data Signals For Global MedTech Compliance

How Slower MDR/IVDR Growth, Submission Quality Issues, and Declining Notified Body Capacity Are Reshaping EU Regulatory Strategy

The latest 2025 survey from Team-NB provides one of the clearest snapshots yet of how Europe’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) ecosystem is evolving.

At first glance, the report appears to show continued growth in MDR and IVDR certifications.

But the deeper signal is far more important:

Europe’s MedTech Regulatory Environment Is Entering a More Mature and More Operationally Challenging Phase

The survey highlights:

• Slowing certificate growth
• Reduced application momentum
• Declining notified body resources
• Persistent submission quality deficiencies
• Longer review timelines
• Increasing complexity in Class D IVDR oversight

This shift has major implications for:

• Medical device manufacturers
• IVD companies
• Regulatory Affairs teams
• Quality & compliance leaders
• Global market access strategies

Key MDR & IVDR Survey Findings for 2025

Overall Certification & Application Trends

The data suggests the MDR/IVDR transition is no longer in its rapid expansion phase.

Instead, the market is entering:

A Capacity-Constrained Compliance Environment

Market Coverage & Regulatory Influence

Team-NB members continue to dominate the European conformity assessment ecosystem.

EU Market Representation

This means Team-NB data provides one of the strongest indicators of overall EU MedTech regulatory trends.

MDR vs IVDR Certificate Distribution

The survey demonstrates that MDR activity still significantly outweighs IVDR certification volumes.

Certificate Distribution Breakdown

However, IVDR complexity continues increasing particularly within higher-risk classifications.

Conformity Assessment Trends

The survey identified clear concentration around specific conformity assessment modules.

MDR Conformity Assessment Distribution

IVDR Conformity Assessment Distribution

This reflects increasing preference for structured quality management and technical documentation pathways.

Review Timelines Continue to Challenge Manufacturers

One of the most operationally important findings:

MDR & IVDR Reviews Still Commonly Require 13–18 Months

Long review timelines continue to affect:

• Product launch planning
• Commercialization schedules
• Revenue forecasting
• Portfolio transition strategies

Manufacturers without proactive submission planning may face significant market delays.

Submission Quality Remains a Major Regulatory Concern

The survey identified persistent deficiencies in application completeness.

MDR Submission Quality Findings

IVDR Submission Quality Findings

This remains one of the largest bottlenecks in the conformity assessment process.

Why Documentation Completeness Matters More Than Ever

Under MDR and IVDR requirements:

Notified Bodies Must Conduct Documentation Completeness Checks Before Assessment Begins

This means:

• Incomplete submissions may not proceed to review
• Technical documentation gaps directly delay assessments
• Poor dossier structure increases regulatory risk
• Weak evidence packages extend approval timelines

Manufacturers increasingly require:

• Structured technical documentation systems
• Stronger internal QC processes
• Cross-functional regulatory coordination
• Earlier submission readiness planning

AI & Annex XVI Applications Declined Sharply

The survey revealed:

AI Device and Annex XVI Applications Declined by Approximately 50%

Potential contributing factors include:

• Regulatory uncertainty
• Classification complexity
• Clinical evidence expectations
• Delayed commercialization strategies

This may indicate manufacturers are becoming more cautious with emerging technologies under current EU regulatory requirements.

IVDR Class D Activity Is Accelerating

One of the strongest growth areas identified was:

High-Risk IVDR Class D Devices

This reflects growing regulatory attention to:

• High-risk diagnostics
• Public health testing
• Infectious disease diagnostics
• Advanced molecular diagnostics

Class D devices continue to face:

• Increased scrutiny
• More extensive performance evidence requirements
• Enhanced conformity assessment oversight

ISO 13485 & MDSAP Certification Activity

Beyond MDR/IVDR certifications, Team-NB members also reported substantial quality system certification activity.

Quality System Certification Data

This reinforces the growing importance of:

• Global quality system harmonization
• Integrated compliance frameworks
• Multi-market regulatory readiness

Global Manufacturer Distribution Is Changing

The survey revealed another major market trend:

Approximately 50% of Micro & Small Manufacturers Certified Under MDR/IVDR Were Located Outside the EU

This demonstrates the increasingly global nature of:

• EU medical device commercialization
• Cross-border regulatory strategy
• International quality system alignment

Notified Body Capacity Is Now Shrinking

For the first time in more than a decade:

Notified Body Staffing Declined

This is one of the most strategically important signals in the report.

Why?

Because shrinking resources combined with:

• Long review timelines
• High submission deficiencies
• Complex regulatory expectations

may increase future bottlenecks across the MDR/IVDR ecosystem.

Operational Impacts Across the Industry

Interestingly, Team-NB also reported:

Overcapacity & Reduced Workloads

This appears linked to:

• Declining submission volumes
• Delayed manufacturer readiness
• Postponed regulatory procedures
• Economic uncertainty within MedTech markets

The result is a paradoxical regulatory environment where:

• Capacity is declining
• Yet many manufacturers still struggle to achieve timely approvals

Certificate Withdrawals Continue to Rise

The survey reported:

1,090 Certificates Withdrawn in 2025

Primary Reasons Included:

• Nonconformities
• Financial instability
• Audit refusal
• Manufacturing cessation

This highlights the growing importance of:

• Ongoing lifecycle compliance
• Quality system sustainability
• Continuous regulatory oversight

What These Trends Mean for MedTech Companies

The 2025 Team-NB survey sends several clear signals.

The Future MDR/IVDR Environment Will Require:

Manufacturers relying on reactive compliance models may face:

• Extended review timelines
• Resource bottlenecks
• Higher regulatory scrutiny
• Increased operational risk

The Strategic Shift in EU MedTech Regulation

Europe’s MDR and IVDR ecosystems are evolving toward:

• Higher documentation quality expectations
• Greater life cycle oversight
• More structured conformity assessment
• Increased operational discipline
• Stronger risk-based evaluation models

The era of minimal compliance is ending.

The future belongs to organizations with:

Strong Regulatory Intelligence & Operationally Integrated Compliance Systems

How Maven Regulatory Solutions Supports MDR & IVDR Compliance

Our Expertise Includes

• MDR & IVDR regulatory strategy
• Technical documentation preparation
• Gap assessment & remediation
• Clinical evaluation support
• IVDR Class D compliance guidance
• ISO 13485 & QMS implementation
• Global market access strategy
• Lifecycle compliance management
• Regulatory intelligence monitoring
• Digital regulatory transformation support

Why Companies Choose Maven

• Global MedTech regulatory expertise
• EU MDR/IVDR-focused compliance strategies
• Science-driven documentation support
• Scalable quality & compliance infrastructures
• End-to-end lifecycle management
• Integrated regulatory intelligence systems

FAQ

1. What is the Team-NB Medical Device Survey?

The Team-NB survey provides annual insights into MDR and IVDR certification activity, notified body operations, application trends, and regulatory challenges across the EU MedTech market.

2. Why are MDR and IVDR timelines still long?

Most reviews continue requiring 13–18 months due to documentation complexity, technical assessment requirements, and submission quality deficiencies.

3. Why are submission completeness checks important?

Notified bodies must verify technical documentation completeness before starting assessments, meaning incomplete submissions can significantly delay approvals.

4. What does the increase in IVDR Class D activity mean?

It reflects growing focus on high-risk diagnostic devices, including infectious disease and advanced molecular diagnostic products requiring enhanced oversight.

5. Why is declining notified body staffing significant?

Reduced staffing may increase future conformity assessment bottlenecks and intensify competition for regulatory review capacity.

6. Why are certificate withdrawals increasing?

Withdrawals are commonly linked to nonconformities, financial instability, audit refusal, or manufacturing discontinuation.

7. What do these trends mean for manufacturers?

Manufacturers increasingly need proactive regulatory planning, stronger technical documentation systems, integrated QMS frameworks, and lifecycle compliance strategies.

8. How can Maven Regulatory Solutions help?

Maven supports MDR/IVDR compliance through regulatory strategy, technical documentation, clinical evaluation support, QMS implementation, and lifecycle compliance management.

Conclusion

The 2025 Team-NB survey highlights a major transition point within Europe’s MedTech regulatory ecosystem.

The industry is moving beyond initial MDR/IVDR implementation toward:

• Operational maturity
• Stronger documentation expectations
• Greater life cycle oversight
• Increased regulatory discipline
• More constrained assessment capacity

For manufacturers, the message is clear:

Regulatory Success Will Increasingly Depend on Submission Quality, Lifecycle Compliance, and Strategic Readiness

Organizations that strengthen regulatory intelligence, technical documentation quality, and operational compliance infrastructure today will be better positioned to navigate the next phase of MDR and IVDR evolution.