New EU Implementing Regulation Introduces Greater Predictability for Conformity Assessment
The European Commission has adopted Implementing Regulation (EU) 2026/977, introducing new conformity assessment requirements for notified bodies under the MDR and IVDR.
European Commission publishes results of 18th Notified Body survey under MDR and IVDR
Latest European Commission data shows MDR and IVDR application volumes, certification timelines, and submission quality based on the 18th Notified Body survey (October 2025 data).