Navigating Challenges in MDR/IVDR Implementation: Team-NB's Strategic Insights
The European Association of Medical Devices Notified Bodies (Team-NB) has taken a strategic stance on the challenges surrounding the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Following their recent general assembly meeting, they outlined key actions and perspectives to address existing issues and enhance regulatory processes.
view the PRESS RELEASE here.
Key Highlights from Team-NB’s Press Release
1. Addressing Operational Bottlenecks
Notified Bodies (NBs) are essential in ensuring medical devices meet safety and performance standards. However, delays in technical documentation submissions and responses during conformity assessments are stretching certification timelines. These issues could exacerbate as the transitional timelines approach their end in 2027–2028. Team-NB advocates for consistent regulatory guidance to mitigate further delays.
2. Streamlining Processes
Team-NB suggests consolidating and simplifying procedures, particularly around classification and qualification of devices. Using mechanisms like the Classification Dispute and Helsinki Procedure for transparent and consistent decision-making is crucial. They also recommend reviewing data only once during a product’s lifecycle to reduce redundant processes and costs.
3. Optimizing Clinical and Technical Standards
The association emphasizes the need to expand the list of “well-established technologies” and enhance the use of Common Specifications to standardize clinical evidence requirements. Modern IT tools are proposed to make conformity assessment processes more efficient, focusing on assessing data rather than extensive documentation.
4. Support for SMEs and Innovation
Given that small and medium enterprises (SMEs) represent a significant portion of Team-NB members’ clients (up to 77%), the organization advocates for increased financial support at the EU level for certification processes. They also back harmonized, fast-track pathways for breakthrough devices to ensure early access to innovative, life-saving products.
5. Commitment to Harmonization and Transparency
An updated Code of Conduct, endorsed by Team-NB members, aims to standardize conformity assessment durations and improve predictability for manufacturers. Harmonizing rules and interpretations by Competent Authorities remains a priority.
Team-NB's Role in Advancing MDR/IVDR Implementation
Team-NB serves as a pivotal organization ensuring high safety standards for medical devices in the EU. They support Notified Bodies through:
- Promoting Innovation: Fostering medical device advancements with robust safety data.
- Guidance and Training: Offering detailed guidance and training to harmonize assessment standards across Europe.
- Task Forces and Collaborations: Establishing task forces to address specific challenges, such as cybersecurity and classification, and engaging with stakeholders to improve regulatory processes.
The Team-NB Academy also facilitates training for both Notified Bodies and manufacturers, aiming to foster harmonized practices and understanding of MDR/IVDR requirements.
Moving Forward: A Collaborative Approach
Team-NB remains committed to improving MDR/IVDR implementation through collaboration with the European Commission, industry, and other stakeholders. By streamlining processes, supporting SMEs, and enhancing harmonization, they aim to ensure safe and innovative medical devices are accessible to patients across Europe.
For more information, visit Team-NB’s website or contact Francoise Schlemmer at schlemmer@team-nb.org.
