EU Notified Bodies Survey 2025 on MDR and IVDR Certifications and Applications

The EU Notified Bodies Survey 2025 provides an essential update on Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) certifications and applications. This survey, covering all 51 designated notified bodies, highlights rising application volumes, certification issuance trends, and ongoing challenges for medical device and IVD manufacturers aiming for regulatory compliance in Europe.

Key Updates in the 2025 Notified Bodies Survey

The latest survey from the European Commission details certification and application statistics as of March 2025. Key takeaways include:

• MDR applications continue to increase steadily, indicating growing industry alignment with EU medical device regulations.

• Despite this growth, the gap between applications and certificates issued highlights capacity challenges among notified bodies.

• IVDR applications show upward trends, especially for Class B and C in vitro diagnostic devices.

• Delays and backlogs remain a concern due to complex review processes and documentation issues.

Impact on Medical Device and IVD Market Access in the EU

This survey underscores how certification timelines and regulatory hurdles affect manufacturers’ market entry strategies. Notified Bodies remain a critical bottleneck, which can delay product launches and impact competitiveness.

Manufacturers should:

• Initiate certification processes early to avoid deadline pressure.

• Ensure thorough and complete technical documentation to reduce assessment delays.

• Monitor notified body availability to choose optimal partners for certification.

How to Comply with MDR and IVDR Certification Requirements in 2025

To navigate the evolving certification landscape effectively:

• Prepare for longer review periods by starting submissions well in advance.

• Invest in detailed technical files addressing MDR/IVDR requirements.

• Leverage early communication with notified bodies to clarify expectations and resolve issues.

Learn More About EU Medical Device Regulations

For additional guidance, see:

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

• CE Mark Notified Body Search and Selection for Medical Device and IVD Companies

• European Commission Notified Bodies Survey PDF

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