Team-NB Publishes Updated Consensus Document on the MDR Certification Process
Team-NB has published Version 2 of its MDR Certification Process Consensus Document, providing detailed guidance on pre-application, application, conformity assessment and surveillance activities for medical device manufacturers under EU MDR 2017/745.
Proposed MDR Article 50 Raises Concerns Over Notified Body Independence and Financial Sustainability
A new legal opinion analyses the European Commission’s proposed MDR Article 50, highlighting potential impacts on notified bodies, SMEs, certification costs, and conformity assessment access.
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).