Medical Device News September 2025 Regulatory Update

Medical Device made Easy Podcast · Sep 4, 2025

Medboard

EUROPE

Guidance on the implementation of the Master UDI-DI – MDCG 2024-14 – rev.1 : https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf

Updated – Notified bodies survey on certificates under MDR and IVDR: https://health.ec.europa.eu/document/download/59b9d90e-be42-4895-9f6f-bec35138bb0a_en?filename=md_nb_survey_certifications_applications_en.pdf

There’s a significant backlog: far more applications submitted than certificates issued, especially for IVDs.

Time for certification: between 13 to 18…