The implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the EU has brought significant changes to the regulatory landscape. The 10th Notified Bodies (NB) survey, conducted by the European Commission in mid-2024, offers critical insights into the progress, challenges, and trends in the certification and application process under these regulations.
Overview of the Survey
This comprehensive survey collected data from 50 notified bodies designated under MDR and/or IVDR, achieving a 100% response rate. Its findings underscore the evolving dynamics of medical device certifications in the EU, driven by the stringent requirements of the MDR (2017/745) and IVDR (2017/746).
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Key goals of the survey included:
- Monitoring the availability of medical devices in the EU market.
- Analyzing conformity assessment trends from the perspectives of notified bodies.
- Identifying areas for improvement in the certification process.
Certification Trends under MDR
As of June 2024, over 26,000 MDR applications had been filed, with approximately 8,900 certificates issued. This represents significant growth since the implementation of MDR, yet highlights the gap between applications lodged and certificates granted.
The survey revealed:
- Application Refusals: Reasons for refusal included incomplete submissions (16%), incorrect product classifications (12%), and insufficient notified body resources (10%).
- Timeframes for Certification: For Quality Management System (QMS) certificates, 53% of notified bodies reported timelines exceeding 13 months. Product certificates took even longer, with 82% requiring at least 13 months for completion.
- Key Challenges: A large proportion of submissions (78%) were deemed incomplete, creating delays in the assessment process.
Certification Trends under IVDR
The IVDR landscape demonstrated parallel challenges, though on a smaller scale. By June 2024, there were 1,747 IVDR applications, resulting in 940 certificates issued.
Key findings include:
- Class D Devices: Applications for the highest-risk in vitro diagnostics reached 585, with 270 certificates issued. Delays often stemmed from resource constraints at notified bodies and manufacturers’ challenges in meeting the enhanced technical requirements.
- Timelines: 58% of IVDR QMS+Product certifications required 13-18 months, reflecting the complexity of IVDR’s risk-based classification system.
- Resource Bottlenecks: Notified bodies highlighted that 60% of the time required for certification was spent by manufacturers preparing documentation, with the remaining 40% allocated to notified body activities.
Impact on Market Availability
The findings highlight a pressing concern: delays in certification threaten the availability of medical devices and diagnostics in the EU. Manufacturers face hurdles in navigating the complex regulatory environment, particularly small and medium enterprises (SMEs), which often lack the resources to meet rigorous conformity assessment requirements.
Recommendations for Stakeholders
To address these challenges, several strategies are recommended:
- Enhancing Collaboration: Strengthen communication between manufacturers and notified bodies to improve submission completeness and streamline reviews.
- Resource Allocation: Governments and regulatory bodies should explore ways to increase resources for notified bodies, enabling them to handle the growing demand for certifications.
- Guidance for SMEs: Provide targeted support and training for smaller manufacturers to help them understand and meet MDR/IVDR requirements.
Looking Ahead
The 10th Notified Bodies survey serves as a valuable barometer for the implementation of MDR and IVDR. While progress has been made, the road ahead requires concerted efforts from all stakeholders to ensure that patients have timely access to safe and effective medical technologies.
By addressing these systemic challenges, the EU can strike a balance between rigorous regulation and innovation in the healthcare sector, fostering a robust medical device ecosystem.
