Team-NB published a position paper on August 10, 2023, to review the new MDR transitional timelines and Notified Body capacity.

The paper highlighted the following key takeaways:

– Limiting new interpretations and requirements from MDCG documents would free up resources for notified bodies. MDCG 2022-14 has not yet delivered all critical deliverables, but notified bodies have made progress in addressing challenges.

– Faster designation of new notified bodies would increase overall certification capacity. Allowing alternative ways to demonstrate staff competence would help designated notified bodies expand capacity.

– The MDR has increased demand for experts, however finding qualified individuals is challenging. Notified bodies could benefit from streamlining authorisation requirements and have begun to harmonise procedures.

– Timely and complete applications from manufacturers are essential for notified bodies to efficiently certify medical devices, and regulatory authorities can help by providing clear, timely, and concise guidance.