The Impact of MDCG 2024-10 on Internal Processes, Timelines, and Team Readiness
The introduction of the MDCG 2024-10 guideline in June 2024 marks a significant shift in how orphan medical devices are evaluated and brought to market in the European Union. This […]
“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits
Author: Stacie Beecham Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, […]
Expert Opinion Panels and New Guidance Documents Are Part of the Changing Landscape of MDR 2017/745
Author: Suzanne Broussard, PhD | February 25, 2022 The European Union (EU) saw 2021 bring important milestones and changes to the implementation of Medical Device Regulation (MDR) 2017/745. Key highlights […]
