Team-NB’s perspective on MDR and IVDR implementation

The European Association of Medical Device Notified Bodies (Team-NB) has released a press statement detailing their perspective on the challenges and priorities surrounding the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Team-NB emphasizes the importance of streamlining regulatory processes, supporting small and medium-sized enterprises (SMEs), and maintaining efficient certification timelines to uphold EU medical device safety standards.

Team-NB plays a vital role in supporting MDR and IVDR by ensuring medical devices and diagnostics meet high safety and performance standards. With increased capacity, Team-NB members continue to handle applications efficiently, though some barriers remain in maintaining steady workflows due to delays from incomplete documentation submissions by manufacturers.

Capacity and resource allocation for Notified Bodies

Most Team-NB members are currently equipped to accept applications for a wide range of devices, with capacity challenges limited to specific device types. However, submission delays can lead to longer certification timelines and potential bottlenecks as the transitional deadlines in 2027 and 2028 approach. Team-NB underscores that maintaining efficient workflows is essential for ensuring smooth implementation.

Advocating for streamlined review processes

Team-NB strongly supports a single-review lifecycle process, reducing redundant data assessments across various procedures, including technical documentation, Periodic Safety Update Reports (PSUR), Post-Market Clinical Follow-up (PMCF), Post-Market Performance Follow-up (PMPF), and Clinical Evaluation Assessment Reports (CEAR). This consolidation would eliminate the need for repeated data review, easing the burden on manufacturers and Notified Bodies alike.

Qualification and classification requirements

Team-NB advocates for consistent, binding clarifications on device qualification and classification, particularly for “well-established technologies” and other complex device types. They recommend expanding the use of Common Specifications (CS) to standardize clinical evidence requirements across device types, providing clear expectations and fostering greater regulatory alignment.

The importance of SMEs in the certification process

Recognizing that SMEs account for approximately 77% of Team-NB’s clientele, the association supports increasing EU financial aid to ease the certification costs for these smaller entities. Currently, some EU Member States offer support, but Team-NB encourages a more uniform approach to reduce financial barriers for SMEs.

Supporting fast-track pathways for breakthrough devices

Team-NB has previously expressed its support for an expedited certification pathway for breakthrough and life-saving devices, especially those addressing rare diseases. Early access to innovative devices would benefit public health and enhance EU healthcare offerings. Team-NB also recommends EU registries and tools like EUDAMED to facilitate post-market monitoring of these devices.

Modern IT solutions for improved conformity assessments

Team-NB suggests that adopting modern IT tools could enhance conformity assessments by enabling direct data review rather than document-based analysis. Streamlining these processes with advanced technology could reduce administrative burdens and make conformity assessments more efficient.

Commitment to transparency and harmonization

In September, Team-NB released an updated Code of Conduct that standardizes duration expectations for various certification processes, improving transparency for manufacturers. The association also supports harmonizing rules for designating and monitoring Notified Bodies to ensure consistency and predictability across the EU.

Summary

Team-NB’s recommendations reflect a commitment to maintaining high standards while addressing the complexities of MDR and IVDR implementation. By simplifying review processes, advocating for increased SME support, and embracing technology, Team-NB aims to streamline the certification pathway and uphold safety and innovation in the EU medical device sector.

Through these measures, Team-NB continues to foster a more efficient and predictable regulatory environment, ensuring that medical devices meet rigorous standards for patient safety across the European Union.

Link to the document:

https://www.team-nb.org/wp-content/uploads/2024/10/PressRelease-Team-NB-20241024.pdf